Chemical generics with reference to biological medicinal products

Background

On 23 April 2026, the Court of Justice of the European Union (CJEU) delivered its judgment in Case C-118/24, ruling on the preliminary questions referred by the French Conseil d’État. The origin of the dispute dates back to 2020, when the ANSM (Agence nationale de sécurité du médicament et des produits de santé, the French medicinal products regulatory authority) authorised the medicinal product Tériparatide Biogaran, a generic medicinal product obtained by chemical synthesis, using as a reference medicinal product Forsteo, a biological medicinal product indicated for the treatment of osteoporosis.

The authorisation of Tériparatide Biogaran was processed through the so-called decentralised procedure. In this procedure, the applicant selects a country to act as "reference Member State" (in this case, Germany), which prepares an assessment report. The other countries in which the authorisation is sought are referred to as "concerned Member States" (in this case, France). Once the report has been approved by all participating States, each one grants its own national authorisation.

This authorisation was challenged before the Conseil d’État by two companies holding biosimilar marketing authorisations containing the same active substance which, unlike Tériparatide Biogaran, are obtained from a biological source and compete in the same market as the reference biological medicinal product. The central argument of the claimants was that a chemically synthesised medicinal product should not be classified as a generic of a biological. Given the doubts regarding the correct interpretation of Directive 2001/83/EC, the French court referred two preliminary questions to the CJEU.

Can a biological medicinal product serve as a reference for a chemically synthesised generic?

The CJEU answers affirmatively. The reasoning starts from the definition of “reference medicinal product” in Directive 2001/83/EC, which does not distinguish between medicinal products obtained by chemical synthesis and biological medicinal products. Moreover, the Directive itself contemplates cases in which a biological cannot serve as the basis for a biosimilar, which confirms, by implication, that a biological medicinal product can indeed serve as a reference in other cases[1].

Therefore, a biological medicinal product can serve as a reference medicinal product for a chemically synthesised generic, provided that the latter cumulatively meets the three requirements of Article 10(2)(b): (i) same qualitative and quantitative composition in active substances; (ii) same pharmaceutical form; and (iii) bioequivalence demonstrated through appropriate bioavailability studies.

The Court specifies that the qualitative composition requirement does not demand exact molecular correspondence: health authorities must verify on a case-by-case basis whether the active substances exhibit considerably different properties in terms of safety or efficacy.

Judicial review and right to a judicial remedy of biosimilar holders

The Court addresses two procedural aspects:

• First, regarding the right to a judicial remedy: can biosimilar holders challenge the authorisation of a generic sharing the same reference medicinal product?
  
  The CJEU declares that, although Directive 2001/83/EC does not expressly regulate this right, neither does it preclude national law from granting biosimilar holders access to the courts to challenge the authorisation of a generic of the same reference medicinal product.
  
  
• Second, regarding the scope of judicial review, the Court rules on a key issue: can the courts of a country that participated in the decentralised procedure review whether the medicinal product was correctly classified as a “generic”? The answer is affirmative. The CJEU bases this conclusion on grounds of public health: if a medicinal product were erroneously classified as a generic, it could be marketed without having undergone the preclinical and clinical trials normally required, which would pose a direct risk to patients. Therefore, allowing national courts to review this classification contributes to ensuring the safety of medicinal products.
  
  However, the Court introduces a clarification: the annulment of a national authorisation does not affect authorisations granted in other Member States. In other words, if a French court were to annul the authorisation in France, the authorisations in Germany or other countries would remain in force.

Conclusions

The judgment recognises the market entry of chemical generics referencing a biological medicinal product. These generics, if they meet the applicable requirements, may benefit from the abridged procedure provided for in Article 10 of Directive 2001/83/EC. This means that the applicant will not be required to provide the results of preclinical and clinical trials if it demonstrates that its medicinal product is a generic of a reference medicinal product authorised for at least eight years in a Member State or in the Union.

At the same time, the judgment recognises the right to a judicial remedy of biosimilar holders to challenge marketing authorisations for generics sharing the same reference medicinal product. Furthermore, each Member State has the power to review whether the classification of a medicinal product as a “generic” is correct, on public health grounds.