C-118/24: CJEU clarifies judicial review and generic classification under EU pharma rules
Background
In its judgment of 23 April 2026, the CJEU addressed the interpretation of Articles 10, 28 and 29 of Directive 2001/83/EC arising from a French marketing authorisation granted to Biogaran for a chemically synthesised teriparatide product (Tériparatide Biogaran), classified as a generic of the reference product Forsteo, which is a biological medicinal product.
The authorisation was granted following the decentralised procedure and subsequently challenged by holders of biosimilar marketing authorisations referencing the same biological product. The case raised two questions: i) access to judicial remedy for a party who does not hold regulatory data exclusivity against marketing authorisations granted to third parties, and ii) the conditions under which a product may qualify as a generic medicinal product.
Judicial review left to Member States
The Court confirmed that Directive 2001/83 does not lay down rules relating to the right to a judicial remedy against an allegedly wrongly granted marketing authorisation issued under the decentralised procedure, when the party bringing the proceedings is not the holder of regulatory clinical data protection, under Article 10 of Directive 2001/83. Therefore, it is within the discretion of the concerned Member States to decide on rules on access to their courts in order for a party, who is not the subject of clinical data protection, to challenge a marketing authorisation issued under a decentralised procedure involving the same reference medicinal product. The Court did not comment on the scope or intensity of such review.
The Court acknowledged that this may give rise to inconsistent outcomes between Member States, but emphasised that such a risk is a necessary consequence of the decentralised procedure as structured under Articles 28 and 29 and cannot be invoked to limit Member States' procedural autonomy. Importantly, an annulment of a national marketing authorisation in one Member State cannot affect the validity of authorisations issued in other Member States or in the reference Member State following the same decentralised procedure.
Generic pathway may rely on biological reference products
The Court clarified that a medicinal product obtained by chemical synthesis may, in principle, be authorised as a generic of a biological reference product, provided it fulfils the criteria in Article 10(2)(b), including requirements relating to composition, pharmaceutical form and bioequivalence. Article 10(1) does not distinguish between chemically synthesised and biological medicinal products and cannot therefore be interpreted as excluding a biological product from serving as a reference product in a generic application. The obligation to submit additional preclinical and clinical data under Article 10(4) applies only where the applicant product is itself biological.
Furthermore, generic classification does not require exact molecular identity; additional data is only required where the active substance fulfils the New Active Substance requirements, i.e. has significantly different properties with regard to safety or efficacy. The criteria must be assessed on a case-by-case basis, and the availability of the generic pathway depends on whether the statutory criteria are met — not on the manufacturing method alone.
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