In its judgment, the General Court of the European Union (the Court) dismissed the action brought by Ferring Pharmaceuticals A/S against a Commission Implementing Decision dated 29 September 2023 granting a marketing authorisation (MA) from the European Medicines Agency (EMA) for the generic medicinal product Degarelix Accord (degarelix acetate).

Ferring held the MA for Firmagon, a degarelix acetate-based product indicated for the treatment of advanced prostate cancer and presented as a powder and solvent for solution for subcutaneous injection. Upon administration, the product spontaneously forms a depot from which the active substance is released over a period of several weeks. Accord Healthcare applied for an MA for Degarelix Accord as a generic medicinal product of Firmagon pursuant to the abridged procedure under art. 10 para. 1 of Directive 2001/83/EC, without conducting a bioequivalence study. Instead, it relied on the exemption applicable for "parenteral solutions" under the EMA's Guideline on the Investigation of Bioequivalence. Following a favourable opinion from the Committee for Medicinal Products for Human Use (CHMP) of the EMA, the Commission granted the MA. Ferring challenged that decision, arguing that Firmagon constituted a "modified release dosage form" and therefore required an in vivo bioequivalence study, and sought annulment of the Commission’s decision.

The Court first rejected Ferring's argument that the EMA and the Commission had relied on the wrong guidance. It held that the authorities had correctly applied the relevant provisions of the Guideline on the Investigation of Bioequivalence concerning parenteral solutions. By contrast, the non-binding draft guidance issued by the US Federal Drug Administration (FDA) had been relied upon Accord Healthcare merely as supplementary support for its application dossier.

On the central question, the Court held that a medicinal product qualifies as a "modified release dosage form" only where the modified release of the active substance is deliberate and results from a specific formulation or manufacturing method. Having reviewed the EPARs for both products and Ferring's own development documentation, the Court concluded that the gel-like depot formed following administration of Firmagon resulted from the inherent self-aggregation properties of degarelix acetate, rather than from an intentionally modified release mechanism. Ferring had, in the Court’s view, merely optimised that naturally occurring process rather than specifically engineering it to achieve modified release.

The Court further noted that the EMA had not consistently classified Firmagon as a "modified release dosage form" and that both Firmagon and Degarelix Accord were appropriately characterised as parenteral solutions for the purposes of the applicable guidance. Accordingly, the Court found no manifest error of assessment on the part of the EMA or the Commission. It also rejected Ferring's arguments concerning differences in quality-control requirements and dismissed two further pleas raised for the first time in the reply as inadmissible pursuant to art. 84 of the Rules of Procedure.

Finally, the Court rejected Ferring's allegation that the principle of good administration had been infringed in connection with the publication of the EPAR. It held that publication eight days after the publication of the MA notice in the Official Journal was reasonable and consistent with art. 13 para. 3 of Regulation (EC) No 726/2004.

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