This post is an attempt to provide salient information on Case C-118/24 concerning EG Labo Laboratoires Eurogenerics SAS and Theramex France SAS vs the French Regulatory Authority (the ANSM) and Eli Lilly.
Specifically, it concerns the opinion of Attorney General Emiliou delivered in a preliminary ruling on 23 October 2025 which attempts to answer the question posed in the title of this post.
Depending on the final outcome of this case, there may be important implications for pharma companies on the economics and speed with which (at least a small number of) follow on products to new biological medicinal products (or biologics) may be licensed in the future.
Background to the case
- Forsteo is a biological medicinal product containing the active substance teriparatide for the treatment of osteoporosis, in the form of a solution for injection (20 micrograms/80 microlitres) in a pre-filled pen.
- Movymia (January 2017) and Livogiva (August 2020) , licensed via the centralised procedure) are both biosimilars of Forsteo
- Tériparatide Biogaran, presented as a generic version of Forsteo, licensed under Article 10(1) of Directive 2001/83, via the decentralised procedure whilst relying on Forsteo, the (biological) medicinal product as ‘reference’ medicinal product.
- Essentially, the case concerns a dispute over the marketing of a generic chemically synthesised medicinal product that uses a biologically derived drug as its reference.
- The case arises from a challenge by pharmaceutical companies against the French health authority’s decision to authorize a synthetic version of the osteoporosis drug Forsteo through an abridged procedure.
- One central issue concerns the jurisdiction of national courts to review administrative decisions made during a multi-country decentralised authorisation procedure.
- Additionally, the court examined whether the definition of a generic medicinal product requires a molecular identity that would preclude a chemically synthesized drug from referencing a biological one.
| Date | Event |
|---|---|
| June 2003 | The European Commission granted an MA to Eli Lilly Nederland BV (following a centralised procedure) for Forsteo, a biological medicinal product containing the active substance teriparatide for the treatment of osteoporosis |
| Jan 2017 and Aug 2020 | The Commission also granted MAs to EG Labo Laboratoires Eurogenerics SAS (‘Laboratoires Eurogenerics’) and Theramex France SAS (‘Theramex’) for two biosimilar versions of Forsteo, namely Movymia (January 2017) and Livogiva (August 2020). Both products were licensed via the centralised procedure. |
| Jan 2019 | Biogaran SAS (‘Biogaran’) submitted an application for an MA for a medicinal product Tériparatide Biogaran, presented as a generic version of Forsteo, under Article 10(1) of Directive 2001/83, via the decentralised procedure, with Germany as the RMS and France as one of the CMSs. |
| Sept 2020 | The ANSM, France granted an MA for Tériparatide Biogaran and recognised it as a generic version of Forsteo. |
| Laboratoires Eurogenerics and Theramex filed an action before the Conseil d’État (Council of State), seeking annulment of that decision. |
Why did Laboratoires Eurogenerics and Theramex file an action before the Conseil d’Etat (Council of State) seeking annulment of the decision by the ANSM to grant an MA for Teriparatide Biogaran?
- The applicants in the main proceedings asked the Conseil d’État (Council of State) to review whether the conditions laid down in Article 10(1) of Directive 2001/83/EC for eligibility for the abridged procedure were satisfied with respect to Tériparatide Biogaran in order to determine whether the use of such a procedure entailed a risk to public health.
- They argued, in essence, that Tériparatide Biogaran has been developed by means of a chemical synthesis, and it cannot therefore be considered as a generic version of Forsteo, which has been obtained biologically.
What was the view of the Conseil d’État (Council of state) once this action was filed by Laboratoires Eurogenerics and Theramex?
- The referring court has doubts, first, whether it can carry out such a review.
- Second, that court also entertains doubts whether the MA granted for Tériparatide Biogaran has a lawful basis.
- It notes that it was granted in the context of an abridged procedure reserved for generics.
- In that respect, it is uncertain whether such a procedure may apply to a chemical medicinal product where its reference medicinal product has been obtained biologically.
What action did the Conseil d’État (Council of state) take?
- In those circumstances, the Conseil d’État (Council of State) decided to stay the proceedings and to refer the following questions to the European Court of Justice for a preliminary ruling.
- You can read the full preliminary ruling here.
- Provided below are the questions as well as the concluding remarks from AG Emiliou’s preliminary ruling of 23 October 2025.
- To better understand the case, you can read the article(s) in the section Further Reading.
Q1) Should Articles 28 and 29 of Directive [2001/83] be interpreted as meaning that a Member involved in a decentralised [MA] procedure without being the reference Member State, is competent, in such a case, to verify that the decentralised procedure was conducted in compliance with the provisions of Directive [2001/83] and that the placing of the medicinal product on the market does not present a potential serious risk to public health within the meaning of Article 29(1) of that directive?
Q2) Should Article 10 of Directive [2001/83] be interpreted as meaning that it precludes [an MA] from being granted to a chemical medicinal product in accordance with the simplified procedure laid down in Article 10(1) of that directive where the reference medicinal product is a biological medicinal product?’
To enable you to to better understand question 2, the following two paragraphs are provided from the preliminary ruling.
By its second question, the referring court asks whether the abridged procedure (which is reserved for generics) may apply when the medicinal product in respect of which an MA has been applied for has been obtained by chemical synthesis, while the relevant reference medicinal product has been obtained biologically.
I recall that, in the main proceedings, it is argued that the MA granted for the medicinal product at issue relies on an unlawful basis because one of the conditions for the use of the abridged procedure, at the end of which that MA was issued, was not satisfied (given that it is argued that that medicinal product cannot be considered to be a generic of the reference medicinal product relied on). That makes it necessary to set out what differentiates, in general, the chemical and biological medicinal products (1) before assessing whether, in the light of the rules provided for in Directive 2001/83, those differences prevent the abridged procedure from applying to a ‘mixed situation’ such as the one in the main proceedings (that is a situation that involves a chemical medicinal product presented as a generic of a biological reference medicinal product) (2).
AG Emiliou’s opinion delivered at the preliminary ruling on 23 October 2025
In the light of all the foregoing considerations, I propose that the Court answer the questions referred by the Conseil d’État (Council of State, France) as follows:
(1) Articles 28 and 29 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
must be interpreted as meaning that they do not preclude a court of a Member State, involved in a decentralised marketing authorisation procedure, without being the reference Member State, which has jurisdiction to hear an action brought against the decision granting a marketing authorisation adopted by the competent authority of that Member State, from verifying whether the medicinal product whose marketing was authorised can be considered a ‘generic medicinal product’ within the meaning of Article 10(2)(b) of Directive 2001/83/EC.
(2) Article 10(2)(b) of Directive 2001/83/EC
must be interpreted as meaning that it does not preclude a marketing authorisation from being granted for a chemical medicinal product, in accordance with the abridged procedure laid down in Article 10(1) of that directive, where the reference medicinal product is a biological medicinal product, provided that the conditions under which the former can be considered a generic of the latter laid down in Article 10(2)(b) of Directive 2001/83 are satisfied.
In summary:
- The Advocate General concluded that EU law allows national courts to conduct such reviews and does not inherently bar the use of the simplified authorization route for chemical copies of biological medicines.
- Ultimately, the opinion emphasizes that public health protection and market competition are best served by allowing generic entry when safety and efficacy are scientifically demonstrated, regardless of the manufacturing method.
Further reading
1. Can a chemically synthesised medicine be authorised as a generic of a biological medicine? And who can challenge this? Alexander Roussanov et al, 18 November 2025, Arnold & Porter, Bioslice Blog