Sara Notario , 7 juin 2026

On 23 April 2026, the Court of Justice of the European Union delivered a judgment on a request for a preliminary ruling made by the Conseil d’État of France. Case C-118/24 arose between EG Labo Laboratoires Eurogenerics SAS (“Eurogenerics”) and Theramex France SAS (“Theramex”), on the one hand, and the Agence nationale de sécurité du médicament et des produits de santé (ANSM, National Agency for Medicines and Health Products Safety) and Biogaran SAS, on the other, concerning decisions granting Biogaran marketing authorisation (‘MA’) for the medicinal product Tériparatide Biogaran.

Forsteo is a biological medicinal product intended for the treatment of osteoporosis by stimulating calcium absorption and bone formation. It contains teriparatide which was produced using recombinant DNA technology. On 10 June 2003, Eli Lilly Nederland BV received ‘MA’ to place Forsteo on the market, thereby enabling it to serve as a reference medicinal product. Pursuant to Articles 6 and 8 of Directive 2001/83, in conjunction with Article 10 of Regulation 726/2004, a reference medicinal product is a medicinal product that has been granted ‘MA’ on the basis of a dossier including results of pharmaceutical, pre-clinical tests and clinical trials, according to the procedure of the foregoing Directive and Regulation. The ‘MA’ in centralized procedure is based on a following a scientific opinion of the European Medicines Agency, however, the final decision is taken by the European Commission. Through decisions of 11 January 2017 and 27 August 2020, the European Commission granted MA to Eurogenerics and Theramex for Movymia and Livogiva in the centralized procedure, as two biosimilar medicinal products to Forsteo. Biological medicinal products cannot be identical due to their complexity; therefore they are considered biosimilars. On 31 January 2019, Biogaran submitted an application under the decentralised procedure for a ‘MA’ for Teriparatide Biogaran, intended as a generic medicinal product of Forsteo, whose active substance is obtained by chemical synthesis. Under Article 10(1) of Directive 2001/83, generic medicinal products may be placed on the market through the abridged procedure, which exempts applicants from the requirement to provide pre-clinical tests and clinical trials. Article 10(2)(b) states that generic medicinal products must satisfy three conditions: the same qualitative and quantitative composition in active substances, the same pharmaceutical form and bioequivalence with the reference medicinal product confirmed by appropriate bioavailability studies. According to Article 28(1) of the Directive, the applicant requests the reference member state and member states concerned in the submitted application, and in this case, Germany acted as the reference Member State, while France, acted as the concerned Member State. Following completion of the decentralised procedure, Director-General of ANSM issued two decisions: the first from 1 September 2020 recognized Tériparatide Biogaran as generic medicinal product and the second from 10 November 2020 constituted a generic group with reference medicinal product Forsteo and generic medicinal product Tériparatide Biogaran. Eurogenerics and Theramex brought applications before the Conseil d’État seeking, on the one hand, to have the ANSM decisions set aside, and, on the other hand, to annul the implied decisions of the Director-General rejecting their administrative appeals against the first-instance decisions of ANSM. In light of the above, the referring court stayed the proceedings and referred the following questions to the Court of Justice for a preliminary ruling: whether the Directive should be interpreted as meaning that court has jurisdiction to verify the decentralized procedure under Directive 2001/83, whether, pursuant to that, the placing the medicinal product present a potential risk to public health and should abridged procedure be applied even when the method of obtaining the active substance is different. Regarding the first question, the Directive does not expressly regulate judicial review of MA decisions; therefore, Member States may determine procedural rules in this regard. However, national courts must ensure that the objectives of the Directive are effectively achieved in the sense that proper implementation of EU law is ensured. The protection of public health is an objective that falls within the scope of the Directive, as reflected in Recital 2 of Directive 2001/83. In response to the first question, the Court held that Member States may provide that national courts have jurisdiction to review decisions regarding the qualification of medicinal product as a generic. In response to the second question, the Court stated that the Directive 2001/83 does not distinguish between biological and chemically synthesised active substances with regard to the manner in which the active substance is obtained. Article 10(2) gives the comprehensive definition of a generic medicinal product which includes medicinal products obtained in chemical synthesis, even when the reference medicinal product is of biological origin.

This case highlights the institutional role of national courts within European Union law. The Court distinguishes between the objectives set out in the Directive 2001/83 and the methods of pursuing those objectives through implementation of this Directive. In these circumstances, on the one hand, the relevant objective is the protection of public health, therefore, it falls within the jurisdiction of national courts in each Member State, and on the other hand, Member States should choose the most effective way to implement directives and they may provide that national courts have jurisdiction to review decisions adopted in the decentralised procedure. Furthermore, the judgement clarifies that the method of obtaining reference medicinal products may differ from the method of obtaining generic medicinal products. The difference between methods of obtaining the active substance is not directly regulated by the Directive, thus, it must be interpreted systematically in conjunction with other provisions regarding generic medicinal products.