Judgment of the General Court (Eighth Chamber) 2 September 2026

JUDGMENT OF THE GENERAL COURT (Eighth Chamber)

2 September 2026 ( * )

( Medicinal products for human use – Generic medicinal products – Marketing authorisation for the medicinal product for human use Degarelix Accord – degarelix acetate – Lack of bioequivalence study with the reference medicinal product – Article 10(1) and (2) of Directive 2001/83/EC – Manifest error of assessment – Principle of good administration )

In Case T‑12/24,

Ferring Pharmaceuticals A/S, established in Kastrup (Denmark), represented by F. Pochart, E. Mignon and D. Zygas, lawyers,

applicant,

v

European Commission , represented by E. Mathieu and A. Spina, acting as Agents,

defendant,

supported by

European Medicines Agency (EMA), represented by H. Kerr, M. van Egmond and G. Gavriilidou, acting as Agents,

intervener,

THE GENERAL COURT (Eighth Chamber),

composed, at the time of the deliberations, of D. Petrlik, acting as President, K. Kecsmár and S. Kingston (Rapporteur), Judges,

Registrar: S. Spyropoulos, Administrator,

having regard to the written part of the procedure,

having regard to the applicant’s request, made pursuant to Article 109(2) of the Rules of Procedure of the General Court, that the case be partially heard in camera and the decision of the General Court, having heard the other parties, to grant that request,

further to the hearing on 18 September 2025,

gives the following

Judgment

1 By its action under Article 263 TFEU, the applicant, Ferring Pharmaceuticals A/S, seeks the annulment of Commission Implementing Decision C(2023) 6669 (final) of 29 September 2023 granting marketing authorisation for the medicinal product for human use Degarelix Accord – degarelix acetate (‘Degarelix Accord’), under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) (‘the contested decision’).

Background to the dispute

2 The applicant is the holder of a marketing authorisation (MA) for the medicinal product Firmagon, which contains the active substance degarelix acetate.

3 Firmagon is used to treat adult male patients with advanced hormone-dependent prostate cancer. According to the Summary of Product Characteristics in the European Public Assessment Report (EPAR), produced by the Committee for Medicinal Products for Human Use (‘the CHMP’) of the European Medicines Agency (EMA) under Article 13(3) of Regulation No 726/2004, Firmagon takes the form of a powder and solvent for solution for injection, intended for subcutaneous use. Following administration of the solution, the injected liquid spontaneously forms a depot from which the active substance is released into the body over a period of several weeks.

4 Degarelix acetate is a synthetic hormone blocker which mimics the gonadotrophin-releasing hormone and directly blocks its effects. By doing so, the substance reduces the level of the male hormone testosterone that stimulates prostate cancer.

5 On 23 June 2022, Accord Healthcare SLU filed an MA application for the medicinal product Degarelix Accord, pursuant to Article 4(1) of Regulation No 726/2004, read in conjunction with Article 3(3) thereof. Accord Healthcare presented Degarelix Accord as a generic version of Firmagon, containing the same active substance, degarelix acetate, and having the same pharmaceutical form, namely a powder (composed of the active substance and mannitol) and a solvent (sterile water), administered by the same route, namely subcutaneous injection.

6 With regard to the clinical aspects, Accord Healthcare’s MA application contained, in particular, a summary of the pharmacokinetics and pharmacodynamics, as well as of the efficacy and safety, of degarelix acetate. It did not contain any bioequivalence study of Degarelix Accord with the reference medicinal product.

7 On 20 July 2023, the CHMP delivered a positive opinion recommending the grant of an MA for Degarelix Accord.

8 By letters dated 11 and 12 September 2023, addressed respectively to the European Commission and to the EMA, the applicant raised objections to the issue of an MA for Degarelix Accord. In essence, the applicant stated that Firmagon was not a ‘solution’ but a ‘modified release dosage form’, which required Accord Healthcare to present an in vivo bioequivalence study of its medicinal product and the reference medicinal product.

9 On 29 September 2023, the Commission adopted the contested decision on the basis of Article 10(2) of Regulation No 726/2004. The MA granted to Accord Healthcare is registered in the Union Register of Medicinal Products under the reference EU/1/23/1753 (Article 1 of the contested decision).

10 By letter of 2 October 2023, the Commission informed the applicant that, as confirmed by the EMA, which had been consulted by it on that point, the applicant’s letters referred to in paragraph 8 above ‘[did] not contain any new scientific elements that [had] not been considered by the CHMP in forming their opinion on 20 July 2023 and assessing the quality, safety and efficacy of [Degarelix Accord]’.

11 On 8 November 2023, the EPAR concerning Degarelix Accord, containing the opinion of the CHMP, was published by the EMA.

Forms of order sought

12 The applicant claims that the Court should:

– annul the contested decision;

– order the Commission and the EMA to pay the costs.

13 The Commission, supported by the EMA, contends that the Court should:

– dismiss the action;

– order the applicant to pay the costs.

Law

14 In support of its action, the applicant puts forward, in essence, three pleas in law in the application. In the reply, it put forward two additional pleas in law.

15 As a preliminary point, it is appropriate to examine the applicant’s applications for the omission of data other than personal data of natural persons vis-à-vis the public.

The applications for the omission of data

16 By documents of 29 February, 31 May and 9 December 2024, the applicant applied for the omission of data other than personal data of natural persons vis-à-vis the public, in accordance with Article 66a of the Rules of Procedure of the General Court.

17 Those applications concern data contained in the application initiating proceedings, the reply and the annexes thereto, and in the observations submitted by the applicant on the statement in intervention, and seek to protect business secrets.

18 In reconciling the need to make judicial decisions public, on the one hand, and the right to protection of personal data and of business secrets, on the other, the court must seek, in the circumstances of each case, to find a fair balance, taking into account the public’s right of access to judicial decisions (judgment of 27 April 2022, Sieć Badawcza Łukasiewicz – Port Polski Ośrodek Rozwoju Technologii v Commission , T‑4/20, EU:T:2022:242, paragraph 29).

19 Moreover, the publicity of judicial decisions is aimed at ensuring scrutiny of the judiciary by the public and constitutes a basic safeguard against arbitrariness (ECtHR, 16 April 2013, Fazliyski v. Bulgaria , CE:ECHR:2013:0416JUD004090805, § 69).

20 In the present case, the data which the applicant seeks to have omitted vis-à-vis the public relate to the manufacturing process for Firmagon and its influence on in situ fibrillation and aggregation of degarelix acetate, as well as to the validation methods used for that medicinal product and their results.

21 Since the data relied on constitute business secrets of a commercial, competitive, financial or accounting nature, are not accessible to third parties and are not historic, the Court has decided to grant the applicant’s applications.

The first plea in law, alleging a ‘violation of essential procedural requirements’

22 The first plea in law is, in essence, divided into two complaints. By its first complaint, the applicant alleges that the EMA failed to apply its guideline on the investigation of bioequivalence (EMA Guideline on the Investigation of Bioequivalence, CPMP/EWP/QWP/1401/98 Rev. 1/ Corr), adopted on 10 January 2010 (‘the Guideline on the investigation of bioequivalence’) to the MA application for Degarelix Accord. By its second complaint, the applicant alleges that the EMA relied, instead, on draft guidance from the Food and Drug Administration (United States; FDA) on degarelix acetate dating from March 2021 (‘the FDA draft guidance’) in order, wrongly, to exempt Accord Healthcare from providing a bioequivalence study of its medicinal product with the reference medicinal product in the context of the MA application for Degarelix Accord.

The first complaint

23 The applicant submits that the EMA and the Commission deviated without justification from the Guideline on the investigation of bioequivalence, which required such an investigation to be carried out between Degarelix Accord and Firmagon prior to the granting of an MA to Accord Healthcare, referring instead to the FDA draft guidance. The applicant submits that deviations from the EMA guidelines, though not prohibited, must be justified, which is not the case here. In doing so, the EMA and the Commission violated an essential procedural requirement.

24 Supported by the EMA, the Commission contends that the applicant’s arguments should be rejected.

25 In that connection, it is appropriate to set out, as a preliminary point, the regulatory framework of the contested decision.

26 The MA for Degarelix Accord was granted at EU level, by the contested decision, following the abridged MA application procedure for generic medicinal products provided for in Article 10(1) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive (EU) 2022/642 of the European Parliament and of the Council of 12 April 2022 (OJ 2022 L 118, p. 4) (‘the abridged procedure’).

27 Article 10(1) of Directive 2001/83 establishes a derogation from Article 8(3)(i) of that directive for certain MA applications for generic medicinal products.

28 Thus, in accordance with the first sentence of Article 10(1) of Directive 2001/83, the applicant seeking an MA for a generic medicinal product is not required to provide the results of pre-clinical tests and of clinical trials if he or she can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 of that directive for not less than eight years in a Member State or in the European Union.

29 The abridged procedure is then based on a dossier referring to the pre-clinical and clinical data produced and submitted by the holder of the MA for the reference medicinal product.

30 The procedure established by the first sentence of Article 10(1) of Directive 2001/83 enables an applicant for an MA for a generic medicinal product to save the time and expense necessary in order to gather the pre-clinical and clinical data. It also avoids, on public policy grounds, the repetition of tests on humans or animals where not absolutely necessary (see, by analogy, judgment of 3 December 1998, Generics (UK) and Others , C‑368/96, EU:C:1998:583, paragraph 4).

31 Under the abridged procedure, the obligation to carry out pre-clinical tests and clinical trials is replaced by an obligation to demonstrate that the proprietary medicinal product is so similar to a proprietary product which has been authorised and marketed for several years that it does not differ significantly from that product as regards safety and efficacy and is therefore essentially similar to the already authorised product (see, to that effect and by analogy, judgment of 3 December 1998, Generics (UK) and Others , C‑368/96, EU:C:1998:583, paragraph 24).

32 Article 10(2)(b) of Directive 2001/83 sets out the conditions under which a medicinal product may be classified as a ‘generic medicinal product’ falling under the abridged procedure. It lists three conditions ensuring that two given proprietary medicinal products are essentially similar. First, the generic medicinal product is a medicinal product with the same qualitative and quantitative composition in active substances as the reference medicinal product. Secondly, it must have the same pharmaceutical form as the reference medicinal product. Thirdly, its bioequivalence with the reference medicinal product must be demonstrated by appropriate bioavailability studies.

33 Article 10(2)(b) of Directive 2001/83 states, as regards the third condition relating to the requirement of bioequivalence between the medicinal products, that ‘bioavailability studies need not be required of the applicant if he can demonstrate that the generic medicinal product meets the relevant criteria as defined in the appropriate detailed guidelines.’

34 In addition, point 2(b) of Part II of Annex I to Directive 2001/83 provides, inter alia, that MA applications for generic medicinal products must contain ‘data showing bio-availability and bio-equivalence with the original medicinal product’ and that ‘the non-clinical/clinical overviews/summaries shall particularly focus on … an evaluation of the bio-equivalence studies or a justification why studies were not performed with respect to the guideline on “Investigation of Bio-availability and Bio-equivalence”’.

35 In that context, the EMA adopted the Guideline on the investigation of bioequivalence referred to in paragraph 22 above, which states the requirements relating to the design, conduct and evaluation of bioequivalence studies.

36 As is apparent from the Guideline on the investigation of bioequivalence, the demonstration of bioequivalence between a generic candidate product and the reference product does not always require a bioequivalence study. There are circumstances in which the need to carry out such studies may be subject to an exemption or a waiver. To benefit from such an exemption or waiver, the applicant must justify why it was not necessary to conduct a bioequivalence study under that Guideline.

37 In particular, the Guideline on the investigation of bioequivalence provides, in Section 2 (p. 4), that it ‘focuses on recommendations for bioequivalence studies for immediate release formulations with systemic action’. It also sets out the relevant criteria by which the applicant may be exempted from bioavailability studies. Accordingly, Appendix II to the Guideline on the investigation of bioequivalence contains a part entitled ‘Parenteral solutions’, which provides that, ‘in the case of other parenteral routes, e.g. intramuscular or subcutaneous, and when the test product is of the same type of solution (aqueous or oily), contains the same concentration of the same active substance and the same excipients in similar amounts as the medicinal product currently approved, bioequivalence studies are not required.’

38 By its line of argument, the applicant claims that the EMA and the Commission deviated without justification from the Guideline on the investigation of bioequivalence.

39 However, it is apparent from the EPAR for Degarelix Accord that the CHMP granted an exemption from providing a bioequivalence study by applying the exemption conditions provided for, in respect of parenteral solutions, in Appendix II to the Guideline on the investigation of bioequivalence and set out in paragraph 37 above.

40 The CHMP stated, in Section 2.4 of the EPAR for Degarelix Accord, entitled ‘Clinical aspects’ (p. 17), that ‘for the clinical assessment [the] Guideline on the Investigation of Bioequivalence … in its current version [was] of particular relevance’. In the part of that section entitled ‘Exemption’, it also stated the following:

‘No bioequivalence study or other biopharmaceutic studies have been performed. These studies are not considered necessary based [inter alia] on the [fact that] [Degarelix Accord] is [a] solution for subcutaneous administration using the same active substance in the same concentration as the reference product and the same excipients in similar amounts as the reference product …’

41 As the Commission notes, the application of the Guideline on the investigation of bioequivalence to the MA application for Degarelix Accord is also mentioned in the CHMP’s Day 120 assessment report of 10 November 2022, in which the following is stated:

‘In line with EMA’s guideline on investigation of bioequivalence, a bioequivalence study is not needed for [a subcutaneously] administered generic if it is qualitatively and quantitatively the same as the reference product.’

42 It follows from the considerations set out in paragraphs 40 and 41 above that the EMA and the Commission applied the Guideline on the investigation of bioequivalence to the MA application for Degarelix Accord, while concluding that the latter satisfied the conditions laid down in that guideline for Accord Healthcare to be exempted from carrying out a bioequivalence study.

43 Consequently, the applicant’s line of argument that the EMA and the Commission disregarded the Guideline on the investigation of bioequivalence during the MA procedure for Degarelix Accord has no factual basis.

44 The question whether the EMA and the Commission committed a manifest error of assessment when applying the Guideline on the investigation of bioequivalence, in so far as that generic candidate medicinal product could not be classified as a ‘parenteral solution’, will be examined in the context of the first complaint of the second plea in law.

45 The first complaint must therefore be rejected.

The second complaint

46 The applicant submits that the EMA and the Commission could not rely on the FDA draft guidance referred to in paragraph 22 above to exempt Accord Healthcare from providing a bioequivalence study between its generic candidate medicinal product and the reference medicinal product. It submits that, first, that FDA document is not final, rather it is still at the draft stage, secondly, it emanates from an agency of a third State and, thirdly, it explicitly indicates that it is non-binding and not for implementation.

47 The Commission contends that the applicant’s line of argument is ineffective and, in any case, unfounded.

48 In that connection, it is not disputed by the EMA and the Commission that, in order to demonstrate that Degarelix Accord was essentially similar to Firmagon, Accord Healthcare decided to follow the recommendations of the FDA draft guidance, in particular by providing in vitro studies.

49 However, as noted by the Commission, that does not provide a basis for the conclusion that the EMA and the Commission itself considered the FDA draft guidance to be the standard in force in the light of which the legality of the MA application for Degarelix Accord had to be analysed.

50 As indicated in paragraphs 39 and 40 above, the EMA granted Accord Healthcare an exemption from providing a bioequivalence study of Degarelix Accord and Firmagon on the basis of the part of Appendix II to the Guideline on the investigation of bioequivalence applicable to ‘parenteral solutions’ and not of the FDA draft guidance.

51 That finding is not called into question by a passage from the EPAR for Degarelix Accord, relied on by the applicant, which states the following:

‘The applicant demonstrated essential similarity to the reference medicinal product Firmagon® based on in vitro studies following FDA’s draft product specific guidance on degarelix acetate, comparing test attributes related to primary and secondary structure, purity, physicochemical properties, gelling kinetics, in vitro drug release, and biological activity.’

52 The passage from the EPAR for Degarelix Accord referred to in paragraph 51 above merely records Accord Healthcare’s choice of methodology for demonstrating that the medicinal products at issue are essentially similar. It does not indicate that the FDA draft guidance was used by the EMA or the Commission as a standard for assessing the need to submit a bioequivalence study of Degarelix Accord and Firmagon.

53 It follows that the EMA and the Commission applied the Guideline on the investigation of bioequivalence to justify the exemption granted to Accord Healthcare from providing a bioequivalence study and not the FDA draft guidance, with the result that the second complaint has no factual basis.

54 The second complaint and, consequently, the first plea in law, must therefore be rejected.

The second plea in law, alleging manifest errors of assessment

55 In the context of the second plea, the applicant submits, in essence, that the EMA and the Commission committed manifest errors as regards the assessment as to whether Degarelix Accord is essentially similar to Firmagon.

56 That plea is divided, in essence, into three complaints.

57 By its first complaint, the applicant criticises the EMA and the Commission for having exempted Accord Healthcare from producing a bioequivalence study comparing Degarelix Accord with Firmagon, even though such a requirement was provided for by EU legislation.

58 By its second complaint, the applicant submits that an exemption from the requirement to provide a bioequivalence study could not be granted on the basis of the FDA draft guidance, the content of which is too vague.

59 By its third complaint, the applicant criticises the EMA and the Commission for having considered Degarelix Accord and Firmagon to be essentially similar, even though Accord Healthcare had not compared those medicinal products using appropriate tests.

The first complaint

60 According to the applicant, the EMA and the Commission committed a manifest error of assessment by considering a bioequivalence study not to be necessary to demonstrate that Firmagon and Degarelix Accord were essentially similar.

61 More specifically, the applicant claims that the EMA and the Commission wrongly applied to Degarelix Accord the provisions of the part of the Guideline on the investigation of bioequivalence relating to ‘parenteral solutions’. According to the applicant, Firmagon and Degarelix Accord are not ‘parenteral solutions’, rather they must be classified as ‘modified release dosage forms’, with the result that the EMA should have followed the requirements provided for on page 24 of that guideline for ‘modified release intramuscular or subcutaneous dosage forms’, which require a bioequivalence study to be carried out to compare that type of medicinal product with the reference medicinal product.

62 Supported by the EMA, the Commission disputes the applicant’s arguments.

63 As regards the scope of the Court’s review, it is apparent from the case-law that, where the administrative authority’s decision is the result of complex technical appraisals, for example, in the medico-pharmacological sphere, those appraisals are in principle subject to only limited judicial review, which means that the EU courts cannot substitute their own assessment of matters of fact for that of the administrative authority (see judgment of 19 November 2008, Schräder v CPVO (SUMCOL 01) , T‑187/06, EU:T:2008:511, paragraph 60 and the case-law cited).

64 Where an EU institution is called upon to make complex assessments, it enjoys a wide measure of discretion, the exercise of which is subject to a judicial review restricted to verifying that the measure in question is not vitiated by a manifest error or a misuse of powers and that the competent authority did not clearly exceed the bounds of its discretion (see judgment of 11 December 2014, PP Nature-Balance Lizenz v Commission , T‑189/13, not published, EU:T:2014:1056, paragraph 34 and the case-law cited).

65 However, while the EU Courts recognise that the administration has a margin of appreciation in economic or technical matters, that does not mean that they must decline to review the administration’s interpretation of economic or technical data. Not only must the EU judicature establish, in particular, whether the evidence relied on is factually accurate, reliable and consistent, but it must also establish whether that evidence contains all the information which must be taken into account in order to assess a complex situation and whether it is capable of substantiating the conclusions drawn from it (see judgment of 19 November 2008, Schräder v CPVO (SUMCOL 01) , T‑187/06, EU:T:2008:511, paragraph 61 and the case-law cited).

66 Even though the judicial review is of limited scope, it requires that the EU institutions which have adopted the act in question must be able to show before the EU judicature that in adopting the act they actually exercised their discretion, which presupposes the taking into consideration of all the relevant factors and circumstances of the situation the act was intended to regulate (judgments of 8 July 2010, Afton Chemical , C‑343/09, EU:C:2010:419, paragraph 34, and of 30 April 2015, Polynt and Sitre v ECHA , T‑134/13, not published, EU:T:2015:254, paragraph 53).

67 In order to establish that an institution committed a manifest error in assessing complex facts such as to justify the annulment of an act, the evidence adduced by the applicant must be sufficient to make the factual assessments used in the act implausible (see judgment of 9 September 2011, Franc e v Commission , T‑257/07, EU:T:2011:444, paragraph 86 and the case-law cited).

68 As regards the CHMP’s opinion, the Court cannot substitute its own assessment for that of that committee. It is only the proper functioning of the committee, the internal consistency of the opinion and the statement of reasons contained therein which are subject to judicial review. As regards the last aspect, the Court is empowered only to examine whether the opinion contains a statement of reasons from which it is possible to ascertain the considerations on which the opinion is based and whether it establishes a comprehensible link between the medical or scientific findings and its conclusions. In that respect, in its opinion the CHMP is obliged to refer to the main reports and scientific expert opinions on which it relies and to explain, in the event of a significant discrepancy, the reasons why it has departed from the conclusions of the reports or expert opinions supplied by the undertakings concerned. That obligation is particularly important in cases of scientific uncertainty. By guaranteeing that the consultation of the committee is inter partes and transparent, that obligation ensures that the substance in question has undergone a detailed and objective scientific assessment, based on a comparison of the most representative scientific opinions with the scientific arguments advanced by the pharmaceutical laboratories concerned (see judgment of 11 December 2014, PP Nature-Balance Lizenz v Commission , T‑189/13, not published, EU:T:2014:1056, paragraph 52 and the case-law cited).

69 Furthermore, it is apparent from the case-law that, in so far as a decision simply confirms the EMA’s opinion, the content of that opinion, and also that of the assessment report on which it is based, should be considered as an integral part of the statement of reasons for that decision, with regard in particular to the scientific assessment of the medicinal product in question (judgment of 24 September 2025, Sanofi v Commission , T‑483/22, EU:T:2025:912, paragraph 78; see, also, judgment of 5 December 2018, Bristol-Myers Squibb Pharma v Commission and EMA , T‑329/16, not published, EU:T:2018:878, paragraph 54 and the case-law cited).

70 In the present case, the contested decision simply confirms the CHMP’s opinion recommending that an MA be granted for Degarelix Accord.

71 In accordance with the case-law cited in paragraph 69 above, the opinion of the CHMP and the EPAR for Degarelix Accord, on which that opinion is based, thus form an integral part of the statement of reasons for the contested decision.

72 Accordingly, the Court’s judicial review, in particular the examination whether there has been no manifest error of assessment, must be carried out in respect of all the considerations set out in the CHMP’s opinion and in the EPAR for Degarelix Accord, on which that opinion is based (see, to that effect, judgments of 24 September 2025, Sanofi v Commission , T‑483/22, EU:T:2025:912, paragraph 81, and of 5 December 2018, Bristol-Myers Squibb Pharma v Commission and EMA , T‑329/16, not published, EU:T:2018:878, paragraph 98 and the case-law cited).

73 In the present case, in order to establish that Firmagon and Degarelix Accord are not ‘parenteral solutions’, but ‘modified release dosage forms’, the applicant puts forward, in essence, four arguments.

74 In the first place, the applicant argues that Firmagon meets the definition of ‘modified release dosage forms’ provided for in the EMA Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms (EMA/CHMP/EWP/280/96 Rev1; ‘the Guideline on modified release dosage forms’). It relies on the mechanism of action of the medicinal product which results from the fact that, following its administration, the liquid injected spontaneously forms a gel at the site of injection, from which the substance is progressively released into the body over a period of several weeks.

75 In that connection, it is apparent from Article 10(2)(b) of Directive 2001/83 that an applicant for an MA may be exempted from bioavailability studies where it can demonstrate that the generic medicinal product meets the relevant criteria set out in the appropriate guidelines, including, in particular, the Guideline on the investigation of bioequivalence and the Guideline on modified release dosage forms.

76 As regards, more specifically, ‘modified release intramuscular or subcutaneous dosage forms’, the Guideline on the investigation of bioequivalence provides on page 24, in the part entitled ‘Modified release dosage forms with systemic action’, that, ‘for suspensions or complexes or any kind of matrix intended to delay or prolong the release of the active substance for [intramuscular] or [subcutaneous] administration, demonstration of bioequivalence follows the rules for [extravascular] modified release formulations, e.g. transdermal dosage forms as per [the] corresponding guideline.’

77 The Guideline on modified release dosage forms states that its primary purpose is to define the studies necessary to investigate the efficacy, safety, biopharmaceutic and pharmacokinetic properties of modified release formulations following oral, intramuscular and subcutaneous administration and transdermal dosage forms in man and to set out general principles for designing, conducting and evaluating such studies.

78 In Section 1.1 thereof, the Guideline on modified release dosage forms defines ‘modified release dosage forms’ as ‘formulations where the rate and/or site of release of the active ingredient(s) are different from that of the immediate release dosage form administered by the same route’, specifying that ‘this deliberate modification is achieved by special formulation design and/or manufacturing methods’.

79 In that connection, the Court notes that, as the EMA observes, in order to meet the definition of modified release dosage forms, the difference as regards the release of the active substance in the organism compared with the immediate release dosage form administered by the same route must be deliberate and must result from a special formulation design and/or manufacturing methods.

80 Accordingly, contrary to what the applicant, in essence, argues, the EMA and the Commission cannot consider to be a ‘modified release dosage form’ a medicinal product that causes a prolonged natural release of the active substance into the patient’s body over a certain period of time, without that release having been deliberately modified in relation to the immediate release dosage form administered by the same route, through a special formulation design and/or manufacturing methods.

81 In the present case, it is therefore necessary to examine whether the EMA and the Commission could consider that the difference as regards the rate and/or site of release of the active ingredient of Firmagon and of Degarelix Accord as compared to those of the immediate release dosage form administered by the same route did not result from a deliberate modification of the release of the active substance in the organism arising from a special formulation design and/or manufacturing methods within the meaning of the Guideline on modified release dosage forms.

82 In the light of the considerations set out in paragraphs 63 to 72 above, the EMA and the Commission must be afforded a broad discretion when applying the definition of ‘modified release dosage forms’ provided for in the Guideline on modified release dosage forms. The evaluations necessary in that context involve the assessment of highly complex scientific and technical facts.

83 The Commission, supported by the EMA, submits that, from the definition of ‘modified release dosage forms’ set out in paragraph 78 above, it follows that the difference as regards the release of the active substance compared to the immediate release dosage form administered by the same route must not result from the natural properties of the active substance at issue. In the present case, according to the Commission, the self-aggregation property of the active substance and the formation of gel in the body, causing the slow release of the active substance, is an intrinsic property of degarelix acetate. Accordingly, the Commission argues that Firmagon was not designed to include a possible depot formation enhancer or any other delayed release system or excipient.

84 In that connection, the Court notes that, in the EPAR for Firmagon, the CHMP stated that, ‘after administration, in contact with body fluids such as plasma, degarelix spontaneously [formed] a gel (naturally forming prolong-release form)’ and that ‘the gelling process [was] mainly influenced by [ confidential ]’. ( 1 )

85 In another passage of the EPAR for Firmagon, the CHMP noted that ‘degarelix was found to be released from the depot form in two phases: a first phase of fast release shortly after dosing followed by a slow release phase’ and that ‘spontaneous formation of the gel-like depot only [occurred] after injection of degarelix suspension at concentrations ≥5mg/mL’.

86 Those findings that the formation of the gelatinous depot and the prolonged release of the active ingredient are spontaneous, on account of the natural property of degarelix acetate of forming a depot, are further confirmed by the Day 80 Critical Assessment Report on Quality, drawn up by the Co-Rapporteur within the CHMP during the MA procedure for Firmagon, which states that the applicant initially investigated whether it would be possible to design a depot formulation by encapsulating the active substance in biodegradable polymers, but that the release kinetics of that design were not adequate. Accordingly, the applicant decided to rely on the natural properties of the active substance, since that more effectively resulted in the formation of a depot and a prolonged release of degarelix.

87 To the same effect, the applicant noted, in its Pharmaceutical Development Report, submitted in 2015 in the context of the MA dossier for Firmagon, as follows:

‘… the drug product is not a sustained release formulation per se. No excipient to sustain the release of degarelix is part of the formulation. It is first in the human body, after injection of the solution, that degarelix forms a gel-like sustained release depot.’

88 Accordingly, in the light of the material in the dossier, the EMA and the Commission did not commit a manifest error of assessment by considering that the difference as regards the rate and/or site of release of the degarelix acetate after the administration of Firmagon and Degarelix Accord as compared to those of the immediate release dosage form administered by the same route did not result from a deliberate modification arising from a special formulation design and/or manufacturing methods and that those medicinal products therefore did not meet the definition of ‘modified release dosage forms’ within the meaning of the Guideline on modified release dosage forms.

89 The applicant’s following arguments do not alter that finding.

90 In order to establish whether the EMA and the Commission committed a manifest error of assessment, the applicant submits, first, that the formulation of Firmagon was deliberately designed to achieve a sustained release of the active substance in the body. According to the applicant, it had identified and optimised the main parameters impacting the formation of the depot in the body, so that the degarelix would be released reliably from the subcutaneous depot, at the appropriate rate and in the appropriate amount. In respect of the parameters which the applicant claims it had specifically adjusted to modify the rate and extent of degarelix release over time, the applicant cites ‘[ confidential ]’.

91 However, the EMA and the Commission were entitled to find, without committing a manifest error of assessment, that the applicant had not deliberately modified the release of the active substance as compared to that of the immediate release dosage form administered by the same route through a special formulation design, but rather that the applicant had simply examined and optimised the natural process of sustained release inherent to the active substance, in order to ensure that that process was unimpeded.

92 Accordingly, the adjustments referenced by the applicant cannot be regarded as a special formulation design within the meaning of the Guideline on modified release dosage forms.

93 The applicant submits, secondly, that it implemented a special manufacturing method for Firmagon within the meaning of the Guideline on modified release dosage forms, which had an impact on the self-aggregation propensity of the active substance at issue. In essence, relying on a [ confidential ] internal paper, the applicant claims [ confidential ]. The applicant claims that those changes in the manufacturing method for the medicinal product affected the quality of that medicinal product with regard to aggregation and depot formation.

94 However, even if, as the applicant argues, the process of fibrillation and aggregation of degarelix acetate is variable, dynamic and impacted by the manufacturing process, the EMA and the Commission did not commit a manifest error of assessment by considering that it was not apparent from the internal paper referred to in paragraph 93 above that the applicant had developed a special manufacturing method enabling, as such, the modified release of the main active ingredient at issue, as compared to that of the immediate release dosage form administered by the same route. The applicant merely claims, on the basis of that paper, that it developed [ confidential ], which allowed the natural self-aggregation property of the active substance at issue to be exploited in the most satisfactory way, in particular in terms of [ confidential ]. The EMA and the Commission were entitled to find that the mere exploitation, in a satisfactory way, of the natural self-aggregation property of the active ingredient concerned was not sufficient to classify such a process as a deliberate modification of the release of that active ingredient as compared to that of the immediate release dosage form administered by the same route.

95 That is all the more so since the internal paper referred to in paragraph 93 above and the letters that the applicant sent to the EMA and the Commission during the procedure for the examination of the MA application for Degarelix Accord, referred to in paragraph 8 above, indicate that the modifications made to the manufacturing method for Firmagon [ confidential ] were introduced with a view to [ confidential ] and not to ensuring, as such, the modified release of the active ingredient at issue, as compared to that of the immediate release dosage form administered by the same route.

96 In view of the above considerations, the applicant’s line of argument and the evidence produced in support do not establish that the finding of the EMA and the Commission, that the modified release of degarelix acetate results from the natural capacity of that substance to self-assemble and form a gel and not from a special formulation design and/or manufacturing methods, is manifestly incorrect.

97 That conclusion is confirmed by the CHMP’s Day 120 assessment report which found that ‘the manufacturing process [of Firmagon] is fairly simple, [ confidential ]’. To the same effect, the EPAR for Firmagon states, in a part relating to the manufacture of the product, that ‘[ confidential ]’ specifying that ‘no special development was necessary.’

98 Moreover, as regards, specifically, the modifications made by the applicant to its manufacturing method for Firmagon, referred to in paragraph 93 above, the EMA noted that, since the adoption of the MA for Firmagon, the applicant had submitted three applications for a variation to the terms of that authorisation pertaining specifically to changes in the manufacturing method of the active substance. However, as the EMA noted, those changes were not considered to be complex and did not require the submission of a bioequivalence study. Accordingly, the EMA cited, for example, the CHMP Assessment Report for Procedure II/22/G, from which it is apparent that the comparison between the quality of batches of Firmagon manufactured with the [ confidential ] method and those manufactured with the new method proposed by the applicant was undertaken by way of a simple in vitro analytical comparison, which has not been disputed by the applicant.

99 The EMA and the Commission were thus entitled to consider, in the context of their broad discretion, that there was no reason to assume that the manufacturing method for Firmagon could not be replicated without affecting the bioavailability of the product. As the Commission notes, Firmagon and Degarelix Accord were compared by Accord Healthcare in the MA application for Degarelix Accord, including by means of in vitro comparative studies, to evaluate whether there were differences in the key parameters that may impact the sustained release of the product, including differences in the manufacturing methods. In that context, it was found that there was no relevant difference between the products.

100 It follows from the foregoing considerations that the EMA and the Commission did not commit a manifest error of assessment by finding that the manufacturing method for Firmagon relied on by the applicant was neither a special formulation design nor a special manufacturing method originating from a deliberate modification of the release of the active ingredient as compared to the immediate release dosage form administered by the same route, within the meaning of the Guideline on modified release dosage forms.

101 In the second place, the applicant argues that the ‘intramuscular/subcutaneous depot formulations’ are a subcategory of ‘modified release dosage forms’ in the Guideline on modified release dosage forms. Since Firmagon is a depot formulation, it necessarily falls within the broader category of ‘modified release dosage forms’.

102 In that connection, it should be noted that ‘intramuscular/subcutaneous depot formulations’ are indeed listed in the Guideline on modified release dosage forms as a category of ‘modified release dosage forms’. It is stated therein that a ‘depot injection’ is ‘usually a subcutaneous or intramuscular product which releases its active compound continuously over a certain period of time’ and that ‘subcutaneous depot formulations include implants.’

103 However, the listing of ‘intramuscular/subcutaneous depot formulations’ among the categories of ‘modified release dosage forms’ in the Guideline on modified release dosage forms cannot exempt them from the general requirement provided for in that guideline, and referred to in paragraph 79 above, that, for a medicinal product to be considered as a ‘modified release dosage form’ within the meaning of that guideline, the modification of the rate and/or the site of release of the active substance in the organism as compared to the immediate release dosage form administered by the same route must be deliberate and must result from a special formulation design and/or manufacturing methods.

104 Consequently, as the Commission and the EMA, in essence, note, the mere fact that the administering of a medicinal product results in the formation of a depot in the organism is not sufficient to bring that medicinal product within the definition of ‘modified release dosage forms’ within the meaning of the Guideline on modified release dosage forms.

105 In the third place, the applicant submits that the EMA has consistently and unequivocally classified Firmagon as a ‘modified release dosage form’ in the past, with the result that it committed a manifest error of assessment by not maintaining that classification in the context of the MA application for Degarelix Accord.

106 However, such a classification of Firmagon is not apparent from the material in the dossier.

107 First, the passages of the EPAR for Firmagon and the EPAR for Degarelix Accord relied on by the applicant in support of its line of argument do not establish that the EMA found either of those medicinal products to be ‘modified release dosage forms’ within the meaning of the Guideline on modified release dosage forms. Those passages merely show the mechanism of action of those medicinal products, by stating that, following administration, upon contact with body fluids, degarelix spontaneously forms a gel which results in delayed and prolonged release of the active ingredient. In that context, reference is made only, on page 6 of the EPAR for Firmagon, to a ‘naturally’ forming prolonged-release form.

108 The same applies to the other documents relied on by the applicant, namely, first of all, the Day 120 list of questions asked in the context of the examination of the MA application for Firmagon, next, the EPAR for another medicinal product, Orgovyx, and, lastly, the European Association of Urology Guidelines on Prostate Cancer of March 2022, which refer to Firmagon as a ‘depot’, ‘depot injection’ or ‘injectable depot formulation’, but in which Firmagon is in no way classified as a ‘modified release dosage form’ within the meaning of the Guideline on modified release dosage forms.

109 In that connection, it should be borne in mind that the mere fact that a medicinal product may be presented in the form of a depot formulation is not sufficient for it to be considered a ‘modified release dosage form’ within the meaning of the Guideline on modified release dosage forms. As stated in paragraph 103 above, the medicinal product must meet the definition of ‘modified release dosage forms’ provided for in that guideline.

110 Secondly, neither the other passages in the Day 120 list of questions nor the Day 180 list of outstanding issues sent by the EMA to the applicant during the examination of the MA application for Firmagon establish that the EMA classified that medicinal product as a ‘modified release dosage form’ within the meaning of the Guideline on modified release dosage forms.

111 The applicant claims that, in those documents, the EMA asked it to provide data on the dissolution of the medicinal product, by citing examples of methods that could be followed in that context, including that of the ‘side-batch approach (cf. the [note for guidance on quality of modified release products] CPMP/QWP/604/96)’. The applicant submits that the fact that the EMA referred to that note supports the applicant’s position.

112 However, the reference to the note referred to in paragraph 111 above shows that the EMA gave the applicant an example of a method that it could use to generate the required information. Accordingly, it does not demonstrate that the EMA classified Firmagon as a ‘modified release dosage form’, in particular when that classification is in no way apparent from the EPAR and the summary of characteristics for Firmagon, in which the EMA merely stated that the medicinal product consisted of a powder and a solvent for solution for injection.

113 The applicant’s line of argument that the EMA consistently and unequivocally classified Firmagon as a ‘modified release dosage form’ in the past must therefore be rejected.

114 In the fourth place, the applicant argues that Firmagon and Degarelix Accord cannot be classified as ‘parenteral solutions’ because they are ‘colloidal dispersions’. Consequently, Degarelix Accord cannot benefit from the exemption from providing a bioequivalence study provided for in the Guideline on the investigation of bioequivalence in respect of ‘parenteral solutions’.

115 The applicant notes that a ‘colloidal dispersion’ is defined in the European Pharmacopoeia as ‘a system in which particles of colloidal size (a dimension of approximately between 1 nm and 500 nm) of any nature (solid, liquid, or gas) are dispersed in a continuous phase of a different composition and/or state’. The applicant submits that it is a matter of scientific fact that Firmagon, when reconstituted, is a colloidal dispersion. The reconstituted degarelix preparation is a clear and colourless liquid, but it contains nano-sized particles that are invisible to the naked eye.

116 In that connection, as is apparent from the Court’s answer to the first complaint of the first plea in law in paragraphs 39 to 42 above, in granting an exemption from providing a bioequivalence study between Degarelix Accord and Firmagon, the EMA and the Commission applied the part of the Guideline on the investigation of bioequivalence relating to ‘parenteral solutions’.

117 As stated in paragraph 37 above, the part of the Guideline on the investigation of bioequivalence relating to ‘parenteral solutions’ provides that bioequivalence studies are not required where the test product is administered in the form of a solution for intramuscular or subcutaneous injection, is of the same type of aqueous or oily solution and contains the same concentration of the same active substance and the same excipients in similar amounts as the medicinal product currently approved.

118 As noted by the Commission and the EMA, the Guideline on the investigation of bioequivalence sets out the requirements for establishing the bioequivalence of two products based on the dosage form of the products concerned, namely the form in which those products are presented for administration. Appendix II is, accordingly, entitled ‘Bioequivalence study requirements for different dosage forms’.

119 As stated in paragraph 112 above, the dosage form of Firmagon, like that of Degarelix Accord, is described in the EPAR for those medicinal products as a ‘powder and [a] solvent for solution for injection’. To that effect, also, the applicant’s pharmaceutical development report, lodged in 2015 in the context of the MA dossier for Firmagon, finds as follows:

‘Reconstitution of degarelix drug product is achieved by adding the solvent to the freeze-dried powder vial and gentle swirling of the vial until complete dissolution of the powder. This process may take up to 15 min for the 80 mg and 120 mg formulations. During the reconstitution procedure, the vial should not be shaken and only turned upside down when extracting solution from a vial. The reconstituted solution should look clear, and be free of undissolved powder and particles.’

120 In that connection, it is also noteworthy that, as relied on by the Commission and the EMA, a discussion on the dosage form of Firmagon took place between the applicant and the EMA during the assessment procedure for the MA application for that medicinal product.

121 In that context, the applicant initially proposed to present Firmagon as a ‘suspension for injection’. However, the CHMP considered the expression ‘solution for injection’ to be more appropriate as regards the pharmaceutical form of that product because it appeared to be a clear solution and because it spontaneously formed a gel only when it came into contact with body fluids such as plasma. The applicant did not dispute that finding following the end of the MA procedure for Firmagon. Accordingly, the dosage form indicated was that of a ‘solution for injection’, as stated in paragraph 119 above.

122 In those circumstances, the EMA and the Commission were entitled to consider that Firmagon and Degarelix Accord had, after reconstitution, the dosage form of a solution for subcutaneous injection, on the understanding that that solution is a parenteral solution within the meaning of the Guideline on the investigation of bioequivalence.

123 Therefore, the applicant has not demonstrated that the EMA and the Commission committed a manifest error of assessment in so far as they applied the part of the Guideline on the investigation of bioequivalence relating to ‘parenteral solutions’ to the MA application for Degarelix Accord.

124 In the light of all the foregoing considerations, the first complaint must be rejected.

The second complaint

125 The applicant submits that the Commission and the EMA committed a manifest error of assessment by accepting Accord Healthcare’s reliance on the FDA draft guidance on degarelix acetate in order to be exempted from providing a bioequivalence study, when the description of the in vitro assays set out in that document was vague, with the result that Accord Healthcare should have relied on the European Pharmacopoeia and should have set up its own protocols for the assays.

126 The Commission contends that the complaint is ineffective and, in any case, unfounded.

127 In that connection, it is not disputed by the EMA and the Commission that, in the context of the MA application for Degarelix Accord, Accord Healthcare followed the FDA draft guidance on degarelix acetate. However, as has been stated in paragraphs 49 to 51 above, it is not apparent from the contested decision, read in conjunction with the CHMP’s opinion, that the EMA and the Commission considered the FDA draft guidance to be the standard in force in the light of which the requirement to provide a bioequivalence study had to be assessed.

128 Furthermore, Accord Healthcare was not prohibited from relying on that evidence to supplement its dossier as long as the EMA and the Commission, for their part, evaluated the compliance of the MA application for Degarelix Accord with the applicable EU legislation, which is the case here.

129 Accordingly, the second complaint must be rejected, since the premiss on which it is based is incorrect.

The third complaint

130 The applicant submits that, for the purpose of the MA for Firmagon, it did not use the European Pharmacopoeia’s protocols, but had to develop its own confidential protocols for the measurement of optical density and the in vitro dissolution of the medicinal product, on account of the physicochemical specificities of degarelix acetate. Accord Healthcare, by contrast, did rely on the European Pharmacopoeia for the measurement of optical density. As regards the measurement of the in vitro dissolution of the medicinal product, it is highly unlikely that Accord Healthcare relied on the protocol for assays that the applicant had developed, given that it was confidential. Accordingly, Accord Health could not have compared its product with the reference product by means of appropriate tests.

131 Supported by the EMA, the Commission contends that the third complaint should be rejected.

132 In that connection, it should be noted that Accord Healthcare submitted in vitro comparative studies in order to demonstrate that Firmagon and Degarelix Accord were essentially similar. Having been exempted from demonstrating the bioequivalence between the two medicinal products at issue, it had to, in particular, in accordance with Article 10(2)(b) of Directive 2001/83, establish that those medicinal products, first, had at least the same qualitative and quantitative composition in active substances and, secondly, the same pharmaceutical form, as stated in paragraph 32 above.

133 The complaint raised by the applicant does not relate to the in vitro comparative studies that Accord Healthcare submitted in order to demonstrate that the medicinal products at issue were essentially similar. The applicant relies on other in vitro studies which Accord Healthcare carried out in connection with the specifications of the product Degarelix Accord as such, with a view to confirming the quality and consistency of that medicinal product at the time of batch release and throughout its expected shelf life.

134 However, as the Commission and the EMA observe, in accordance with Article 10(1) of Directive 2001/83, the possibility for the applicant for an MA for a generic candidate medicinal product to rely on the dossier for a reference product extends only to the pre-clinical tests and clinical trials of the original product, and not to the ‘quality dossier’ concerning the manufacture and characteristics of the active substance and the finished medicinal product. Consequently, an applicant for an MA for a generic candidate medicinal product must submit its own ‘quality dossier’, it being understood that it is not subject to the requirement that the specifications of that generic candidate medicinal product be identical to those of the reference product.

135 Accordingly, the applicant’s line of argument is ineffective, since, in order to call into question the essential similarity between Firmagon and Degarelix Accord, it disputes the tests carried out by Accord Healthcare for the ‘quality dossier’ in connection with the specifications of Degarelix Accord, which are not relevant in that context, rather than the in vitro comparative studies which were submitted by that company in order to demonstrate that the two medicinal products at issue were essentially similar.

136 The other arguments submitted by the applicant must also be rejected.

137 In the first place, the applicant submitted, for the first time in the reply, that, by not requiring Accord Healthcare to include tests for the in vitro dissolution of the medicinal product in the specifications of Degarelix Accord, the EMA and the Commission committed a manifest error of assessment. In so doing, they lowered the level of quality control of a medicinal product intended for patients suffering from serious forms of prostate cancer.

138 However, given that that argument was raised for the first time in the reply, it is inadmissible.

139 Under Article 84 of the Rules of Procedure, no new plea in law may be introduced in the course of proceedings unless it is based on matters of law or of fact which have come to light in the course of the procedure.

140 In the present case, there is nothing to indicate that the argument concerning the reduction in the level of quality control of Degarelix Accord referred to in paragraph 137 above is based on a matter of law or of fact which came to light in the course of the procedure. Consequently, its submission at the stage of the reply is out of time.

141 In any event, the argument concerning the reduction of the level of quality control of Degarelix Accord is not supported by evidence. In that connection, it should be noted that, as the Commission notes, Degarelix Accord was the subject of a full assessment by the EMA in the framework of the evaluation of the MA application for that medicinal product, in accordance with the rules provided for by Directive 2001/83 and Regulation No 726/2004 and the relevant applicable guidelines. That regulatory framework is specifically intended to ensure a high level of protection of public health, while avoiding, on public policy grounds, the repetition of tests on humans or animals where not absolutely necessary (see paragraph 30 above). Moreover, like any other authorised medicinal product, Degarelix Accord is subject to strict obligations of pharmacovigilance and continuing monitoring of its safety following the grant of the MA. Therefore, in the absence of proof by the applicant of a lack of compliance with those rules or a defective application thereof, the mere assertion that the grant of an MA for Degarelix Accord would potentially put public health at risk cannot succeed.

142 To the same effect, the applicant’s similar arguments that, by not requiring an assessment of the release of the active substance of Degarelix Accord by means of validation studies carried out in vivo , the EMA and the Commission potentially put public health at risk, when the medicinal products at issue are used to treat life-threatening diseases, must be rejected. The applicant cannot simply make such an assertion without having identified a rule from the applicable EU legislation and demonstrated that it has been infringed in the present case.

143 In the second place, the applicant submitted, for the first time in its observations on the statement in intervention, that the differences between the specifications of Firmagon and Degarelix Accord demonstrated that, even though they were formally presented as having the same pharmaceutical form, that was not the case.

144 The applicant submits that the EMA considered Firmagon to be a ‘suspension’, since it asked the applicant to develop an in vitro dissolution test for the product specifications of Firmagon, stating that that test was necessary for ‘suspensions’, and it considered Degarelix Accord to be a ‘solution’, since no in vitro dissolution test or substitute was provided for in the specifications of that medicinal product.

145 According to the applicant, it follows that one of the conditions set out in Article 10(2)(b) of Directive 2001/83 for establishing that the reference medicinal product and the generic candidate medicinal product are essentially similar, namely that they have the same pharmaceutical form, is not satisfied and, therefore, that, in the present case, Firmagon and Degarelix Accord cannot be considered to be essentially similar.

146 However, inasmuch as that argument was raised for the first time in the applicant’s observations on the statement in intervention, it is inadmissible for the same reasons as those set out in paragraphs 139 and 140 above.

147 In any event, the argument referred to in paragraph 143 above must be rejected as unfounded. To support its assertion that the EMA considered its medicinal product to be in a different pharmaceutical form from that of Degarelix Accord, namely in the form of a ‘suspension’ rather than a ‘solution’, the applicant relies on exchanges it had with the CHMP before the submission of its MA application for Firmagon.

148 In those exchanges, the CHMP stated, first, that it was not clear from the documentation provided whether the applicant wished to market a ‘powder and [a] solvent for solution for injection’ or a ‘powder and [a] solvent for suspension for injection’ and, second, that, if the formulation were to be injected as a ‘suspension’, it was advisable to develop an in vitro dissolution method for release testing and shelf-life testing of the reconstituted suspension.

149 However, first, those statements were made before the MA application for Firmagon was submitted, in the form of hypothetical assumptions.

150 Secondly, as is apparent from paragraphs 112, 119 and 122 above, the pharmaceutical form of Firmagon and Degarelix Accord is described in the EPAR for each of those medicinal products as a ‘powder and [a] solvent for solution for injection’, with the result that those medicinal products can be considered to have, after reconstitution, the same dosage form of a solution for injection.

151 Thirdly, as the EMA noted, the specifications for Firmagon do not, in any event, currently contain an in vitro dissolution method as such.

152 In its information dossier for the purpose of its future MA application for Firmagon, the applicant had explained to the EMA that the development of an in vitro dissolution test [ confidential ] and it had proposed, consequently, not to include that test in the product specifications, as the results of that test could be predicted by other means, namely on the basis of the results of the optical density and viscosity testing. During the assessment procedure and following exchanges with the CHMP, the MA for Firmagon was finally granted by including, in the product specifications, the optical density increase and an in vitro dissolution test to be carried out only on the first 10 commercial batches.

153 Later, on 29 March 2012, the applicant submitted a variation application for Firmagon to the EMA, requesting an update to the medicinal product specifications based on data from the release of the first 10 commercial batches. In the context of that variation, it was found to be sufficient to include only the optical density and viscosity in the specifications of Firmagon to replace the in vitro dissolution tests.

154 In those circumstances, the applicant cannot maintain that there was a difference as regards the presence of an in vitro dissolution test in the specifications of Firmagon as compared with those of Degarelix Accord.

155 It follows from the foregoing considerations that the applicant has demonstrated neither that the medicinal products at issue had a different dosage form nor that the EMA and the Commission could not, in those circumstances, consider them to be essentially similar within the meaning of Article 10(2)(b) of Directive 2001/83 without committing a manifest error of assessment.

156 In the light of the foregoing considerations, the third complaint and, therefore, the second plea in law, must be rejected.

The third plea in law, alleging breach of the principle of good administration

157 The applicant raises, in essence, a third plea in law, alleging breach of the principle of good administration inasmuch as the EPAR for Degarelix Accord was published out of time, without any justification.

158 The Commission disputes the applicant’s arguments.

159 In accordance with Article 13(3) of Regulation No 726/2004, the EMA is to publish immediately the EPAR drawn up by the CHMP and the reasons for its opinion in favour of granting authorisation, after deletion of any information of a commercially confidential nature.

160 Accordingly, Article 13(3) of Regulation No 726/2004 requires the EMA to publish the EPAR ‘immediately’, without specifying the starting point of that time limit. However, it may be inferred from the positioning of that paragraph after paragraph 2 of that article, which concerns the publication of MA notifications in the Official Journal of the European Union , that it is from that moment that the EMA must immediately publish the EPAR.

161 Furthermore, Article 13(3) of Regulation No 726/2004 accepts that the EPAR may be published only after the deletion of any information of a commercially confidential nature.

162 In that context, it should be noted that the EPAR for Degarelix Accord was published on 8 November 2023, that is to say, eight days after the publication of the notification of the MA for Degarelix Accord in the Official Journal of the European Union . Such a period appears reasonable and compliant with the constraints inherent in the procedure for the publication of EPARs, which entail, in particular, the prior deletion of any information which may be of a commercially confidential nature.

163 Accordingly, that publication occurred without delay in accordance with the requirements stemming from Article 13(3) of Regulation No 726/2004.

164 Furthermore, as the Commission notes, the applicant cannot complain that it did not have sufficient time to prepare its action between the publication of the EPAR for Degarelix Accord and the expiry of the time limit for bringing an action against the contested decision, given that it lodged its action several days before the expiry of that time limit and thus, in any event, did not take advantage of the entire duration of the time limit afforded to it.

165 Accordingly, the third plea in law must be rejected.

Admissibility of the pleas raised for the first time in the reply

166 In the first place, the applicant raises an additional plea in law alleging breach of the principle of the protection of legitimate expectations inasmuch as, by granting an MA to the applicant for Firmagon on the basis of the fact that that medicinal product could be classified as a ‘modified release dosage form’, the Commission gave ‘precise, unconditional and consistent assurances’ that that classification would not change without the applicant’s involvement and that it was in compliance with the applicable rules. According to the applicant, the Commission made a fundamental and unforeseeable change in classification of that medicinal product by treating Firmagon and Degarelix as ‘parenteral solutions’ in the defence.

167 In the second place, the applicant alleges a misuse of procedure inasmuch as the objective of the change in Firmagon’s classification was to allow the EMA and the Commission to apply a less onerous procedure to the MA application for Degarelix Accord, and one less protective of public health.

168 The Commission submits that those new pleas in law are inadmissible and, in the alternative, ineffective.

169 In the present case, it follows from paragraphs 105 to 113 above that the applicant’s argument that the EMA and the Commission changed their position as regards the classification of Firmagon, inasmuch as it had been classified in the past by the EMA as a ‘modified release dosage form’, and only subsequently as a ‘parenteral solution’, must be rejected.

170 Since no change in the position of the EMA and the Commission occurred, the applicant has not shown that its pleas were based on a matter of law or of fact which came to light after the lodging of the application and which justified the introduction of a new plea in law in the course of the proceedings in accordance with Article 84 of the Rules of Procedure.

171 Accordingly, those two pleas in law must be considered inadmissible.

172 In the light of all the foregoing considerations, the action must be dismissed.

Costs

173 Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

174 Since the applicant has been unsuccessful, it must be ordered to bear its own costs and to pay those incurred by the Commission, in accordance with the form of order sought by the Commission.

175 Pursuant to Article 138(1) of the Rules of Procedure, the institutions which have intervened in the proceedings are to bear their own costs. The EMA must therefore bear its own costs.

On those grounds,

THE GENERAL COURT (Eighth Chamber)

hereby:

1. Dismisses the action;

2. Orders Ferring Pharmaceuticals A/S to bear its own costs and to pay those incurred by the European Commission;

3. Orders the European Medicines Agency (EMA) to bear its own costs.

Delivered in open court in Luxembourg on 2 September 2026.

* Language of the case: English.

1 Confidential information redacted.