On 23 October 2025, Advocate General (“AG”) Emiliou delivered his opinion in Case C-118/24: Laboratoires Eurogenerics and Theramex France.[1]

The AG opines on three key questions regarding the use of the decentralised procedure for generic medicinal products:

(i) The national courts of the EU Member States are allowed by EU law to judicially review the legality of a marketing authorisation (“MA”) granted via the decentralised abridged procedure where it is alleged that the medicinal product in question does not meet the criteria of a generic medicinal product. This is applies even if the judicial review is conducted by a national court in an EU Member State other that the reference Member State for the decentralised marketing authorisation procedure.

(ii) The applicant seeking such judicial review does not need to be the marketing authorisation holder for the reference medicinal product or the applicant for the generic marketing authorisation. The applicant could also be a third party with a vested interest, such as the marketing authorisation holder for a biosimilar medicinal product which will be competing with the newly authorised generic medicinal product. This conclusion by the AG remains unaffected by the fact that such applicant  may not be admissible if the action was brought at EU level to the Court of Justice of the European Union (“CJEU”) if the direct and individual concern of the applicant is not demonstrated. According to the AG, it is for the EU Member States in the framework of their procedural autonomy to decide whether a right to challenge an MA exists in these circumstances.

(iii) Chemically synthesised products are not precluded from meeting the criteria to be a generic of a reference biological medicinal product.

This third finding will, if followed by the CJEU, also apply to the centralised marketing authorisation procedure and arguably facilitate market access for synthetic copies of biological medicinal products. It would mean that, in practice, applicants for generics of biological medicinal products would not be required to submit additional pre-clinical and/or clinical data (as opposed to biosimilar applicants) and may potentially benefit, once authorised, from more advantageous pricing and reimbursement conditions (e.g., substitutability at pharmacy level which may not be available for biosimilar medicinal products).

Factual Background

In 2003, the European Commission granted a centralised MA to Eli Lilly Nederland BV for Forsteo, a biological medicinal product containing the active substance teriparatide for the treatment of osteoporosis, in the form of a solution for injection in a pre-filled pen.

In 2019, Biogaran SAS (“Biogaran”) applied for MAs for its product which contained the same active substance and was in the same pharmaceutical form as Forsteo, using the abridged procedure for generic medicinal products (Article 10(1) Directive 2001/83). The difference was that the teriparatide used in Biogaran’s product was derived from a chemical synthesis, unlike Forsteo. The application was made via the decentralised procedure with Germany as the reference Member State, and France as one of the concerned Member States.

Two MA holders for biosimilars of Forsteo, produced from a biological source, brought an action against the French authority, seeking annulment of the MA granted to Biogaran. They argued that Biogaran’s product had been developed by means of a chemical synthesis, and therefore it cannot be authorised as a generic version of Forsteo, which has been obtained biologically.

Can a chemical medicinal product be a generic of a biological medicinal product?

The AG held that the Directive does not preclude an MA from being granted for a chemical medicinal product as a generic of a biological reference medicinal product.

The AG noted that many biological active substances are characterised by microheterogeneity i.e., they have a certain degree of inherent variability due to slight changes in the molecular structure. By contrast, microheterogeneity does not occur in a chemically synthesised product. Whether microheterogeneity actually occurred in Forsteo, and the exact differences it might have caused with Biogaran’s product, was for the EU Member State referring court to verify.

However, the AG drew attention to the various elements of the definition of a generic medicinal product under Article 10(2)(b), namely, the generic and the reference medicinal product should have:

  • the same qualitative and quantitative composition in active substances;
  • the same pharmaceutical form; and
  • bioequivalence.

The AG noted that microheterogeneity may mean there will be a difference of molecular structure between a biological and chemical product, but found that this does not preclude the condition of the ‘same qualitative and quantitative composition in active substances’ being met. 

In his reasoning, the AG referred to the clarification in the definition in Article 10(2)(b) of the Directive which states ‘the different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy’. These differences can lead to changes in the precise molecular structure, and this may lead to the need for additional proof of the safety and efficacy, but the AG argues that the legislature did not intend for those differences to preclude a medicinal product from being considered a generic.

The AG also considered Article 10(4) of the Directive on biosimilar medicinal products. Under that provision, ‘where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided’ to obtain a marketing authorisation (emphasis added).

The AG rejected arguments that Article 10(1) was therefore reserved to chemical products, and argued that the existence of Article 10(4) actually supports his answer. The AG argues that Article 10(4) shows that the Directive acknowledges the particular difficulty of a biological product in ‘copying’ another biological product in an identical manner, while not excluding that possibility in absolute terms.

The AG also rejected arguments that allowing a chemical generic of a biological medicinal product works against the Directive’s aim to avoid obstacles in the development of the pharmaceutical industry and trade in medicinal products as the generic application can only be made after data protection has expired.  In addition, not allowing the generic to refer to a biological medicinal product would mean the applicant for the chemical product would be required to conduct pre-clinical tests and trials (which the regulatory framework seeks to limit) and could result in depriving the market of an alternative product or would negatively affect its price.

Concluding thoughts

Whether the CJEU agrees with AG Emiliou remains to be seen. In particular, AG Emiliou’s answer to this question is certainly intriguing and, if followed by the CJEU, may potentially facilitate market access for synthetic copies of biological medicinal products, as discussed in the introduction. This would certainly have significant practical implications in the EU.

The AG deferred to the referring French national court to ascertain whether the chemically synthesised product actually does meet the definition of generic medicinal products for a biological reference product on the particular set of facts. If the AG Opinion is followed by the CJEU, this is likely to mean national authorities will be faced with determining the exact evidential requirements that companies will need to meet to use the Article 10(1) procedure with a chemically synthesised product and using biological reference medicinal products.

[1] ECLI:EU:C:2025:815

A new policy paper released on 2 November 2025 sets out the MHRA’s proposals on overhauling and transforming the UK regulation of rare therapies.

The intention is for a “bold new rulebook for rare therapies” to be published in 2026. Rare therapies is defined as medicinal products intended to treat rare diseases, specifically, conditions with a prevalence of no more than 5 in 10,000. The Medicines and Healthcare products Regulatory Agency (MHRA)’s press release on the matter provides the concerning statistic that, while ≈3.5 million people in UK are affected by rare diseases (equivalent to one child in every classroom), and many more if carers are taken into account, only 5% of rare diseases have approved treatment. An intention of the reform is therefore to shorten the time for development of therapies for such conditions from initial discovery through to the stage of delivery to patients.

The MHRA aims to position the UK as a global leader in developing, regulating, and integrating rare therapies into healthcare. This policy paper outlines a new regulatory framework designed to accelerate access to innovative treatments for rare diseases while maintaining safety and evidence standards.

The initiative is supported by the newly formed Rare Disease Consortium, a collaborative effort made up of various different stakeholders including the MHRA, NICE, DHSC, NHS England, as well as patients and their representatives, academia and research institutions and industry.

A draft of the framework is anticipated to be available by Spring 2026, with external review in the first half of the year. A public consultation will also be conducted in 2026.

Continue Reading Rewriting the Rulebook: MHRA’s Vision for Rare Disease Therapies

Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2025 from the the United Kingdom, and European Union.

This month, the EU and UK have been actively processing the future of AI development and regulation in life sciences and health care through a combination of legislative initiatives, opportunities for stakeholder engagement, and investment in infrastructure. In the EU, the European Commission has published draft guidance on reporting serious AI incidents under the AI Act, and the European Medicines Agency has initiated a stakeholder survey to define AI priorities in medicines regulation. In the UK, the UK government has announced a National Commission on the Regulation of AI in Healthcare and a new AIR-SP cloud platform. These developments signal a shift from theoretical regulation to practical implementation. There have also been two important decisions from the Court of Justice of the European Union refining the legal boundaries of digital health services and data protection.

Continue Reading Virtual and Digital Health Digest – October 2025

[1] This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

Radiopharmaceuticals are a special type of medicinal products. Where they are prepared industrially or by a method involving an industrial process and are intended to be placed on the market in the European Union (‘EU’), they are subject to the rules of Directive 2001/83/EC on medicinal products for human use (the ‘Medicines Directive’). In addition, if patients are treated with radiopharmaceuticals, account should be taken of Directive 2013/59/EURATOM (the ‘Euratom Directive’) which lays down basic standards for the protection of individuals against radiation exposure.

Continue Reading Development of a new EMA guideline on the clinical evaluation of ready to use radiopharmaceuticals[1]

Following a two year investigation, the UK’s Competition and Markets Authority (“CMA”) has issued its provisional findings in which it proposes to impose significant obligations on veterinary business.

Continue Reading The Dog That Barks: The UK’s CMA is proposing major reforms to Veterinary Businesses

On 10 October 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) announced the early launch of the “Aligned Pathway”. This is a joint initiative designed to streamline  the scheduling of the regulatory approval and health technology assessment processes in order to reduce the time before a new medicine is available on the NHS following the grant of the marketing authorisation (MA). The pathway supports the UK Government’s ambitions outlined in the 10-Year Health Plan for England and the Life Sciences Sector Plan to accelerate access to medicines and reduce regulatory burden, as discussed in our blog here.

Continue Reading MHRA and NICE launch aligned approvals pathway

On 8 September 2025, the Court of Justice of the European Union (CJEU) received a preliminary request from the Bundesverwaltungsgericht, the German Federal Administrative Court BVerwG, referring a series of questions seeking interpretation on the applicability of certain rules to parallel trade of medicines, including whether German language and packaging requirements are proportionate or compatible with EU law.  The request follows an order for a preliminary reference made by the BVerwG in March 2025.  Notably, the request does not disclose the identity of the parallel importer, the manufacturer of the medicinal product, or the name of the product itself.

Continue Reading CJEU to Clarify Rules on Packaging Requirements in Parallel Trade of Medicines

Article 22 and the Pharma Context

Competition authorities in Europe have for years grown increasingly concerned about so-called “killer acquisitions,” particularly in life sciences where targets often have high innovation potential but little or no turnover. These are transactions where the acquired company’s competitive significance lies in its pipeline, R&D or intellectual property rather than its financials. Such deals can escape traditional turnover-based merger control thresholds, yet – the authorities argue – may still raise serious concerns about future (i.e., potential) competition and innovation. That said, the label “killer acquisition” is something of a misnomer. In practice, transactions undertaken solely to eliminate innovation from a smaller rival are exceedingly rare.

To address this risk, the European Commission has encouraged greater use of Article 22 of the EU Merger Regulation (EUMR), which allows Member States to refer cases for EU review even if they do not meet EU thresholds. Subject to potential further developments, two recent judgments, the Court of Justice’s ruling in Illumina/GRAIL and the General Court’s decision in Brasserie Nationale, now provide the leading interpretation of how Article 22 operates in practice, particularly in relation to call-in powers and timing of referrals.

Continue Reading Article 22 Trends in Pharma M&A: Call-In Powers and Timing

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations (“MA”) for medicinal products) (“Variations Guidelines”).

The new 2025 Variations Guidelines replace the older 2013 Variation Guidelines, and support the implementation of the amended Regulation (EC) No 1234/2008 (“Variations Regulation”) (see our BioSlice blog post), which entered into force in January 2025. The Variations Guidelines provide detailed guidance for marketing authorisation holders (“MAH”) on modifying and updating their MAs, the procedures to follow and the related requirements.

Overall, the new Guidelines provide greater flexibility and clarity in certain aspects of the variation procedures. At the same time, they introduce new obligations for MAHs that should be taken into account by pharmaceutical companies going forward.

In this blog, we highlight some of the key changes introduced by the Variations Guidelines.

Continue Reading European Commission Publishes New Variation Guidelines for Medicines

On 8 September 2025, the European Commission published a call for evidence on “the targeted revision of the EU rules for medical devices and in vitro diagnostics”. This is part of the Commission’s on-going “targeted evaluation” of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR), with the aim of identifying methods to tackle critical issues experienced throughout the industry caused by the regulations.

Continue Reading European Commission’s call for evidence on the revision of the MDR/IVDR