French biosimilar substitution rules expand to include ophthalmic therapies

The Ministry of Health, Families, Autonomy and Persons with Disabilities (Ministère de la Santé, des Familles, de l'Autonomie et des Personnes handicapées) and the Ministry of Action and Public Accounts (Ministère de l'Action et des Comptes publics) issued the Decree of 4 February 2026 amending the Decree of 20 February 2025 establishing the list of similar biological groups substitutable by the retail pharmacist (Arrêté du 4 février 2026 modifiant l'arrêté du 20 février 2025 fixant la liste des groupes biologiques similaires substituables par le pharmacien d'officine) on 6 February 2026. This measure represents a strategic expansion of the 2025 substitution doctrine – moving France closer to a pharmacy-led biological market.

The regulation adds ten distinct biological groups to the substitution list. The most significant additions target the high-cost ophthalmology segment – specifically including aflibercept (Eylea®) and ranibizumab (Lucentis®). It also updates specific conditions for established groups like adalimumab (Humira®) and etanercept (Enbrel®). This shift transfers institutional decision-making power from the prescribing physician to the pharmacist – allowing the latter to determine the final product dispensed at the pharmacy counter.

Catherine Delpech, the Sub-Director of Healthcare System Financing (Sous-directrice du financement du système de soins), and Emmanuelle Cohn, the Sub-Director of Health Products Policy and Quality of Practices and Care (Sous-directrice de la politique des produits de santé et de la qualité des pratiques et des soins), signed the order. Their coordination underscores the dual objective of the French Healthcare System (Système de santé français) – to drive clinical biosimilar uptake while securing fiscal savings for the Social Security (Sécurité sociale).

The decree mandates that pharmacists provide educational support for administration devices. Patients retain the right to return to the reference biological if they face difficulties. This expansion will likely accelerate the erosion of market share for reference brands as they lose their hold over the point of sale.

Source: Minister of Health, Families, Autonomy and Persons with Disabilities and Minister of Action and Public Accounts.
Link: Arrêté du 4 février 2026 modifiant l'arrêté du 20 febbraio 2025 fixant la liste des groupes biologiques similaires substituables par le pharmacien d'officine et les conditions de substitution et d'information du prescripteur et du patient telles que prévues au 2° de l'article L. 5125-23-2 du code de la santé publique (Decree of 4 February 2026 amending the Decree of 20 February 2025 establishing the list of similar biological groups substitutable by the retail pharmacist).
Date: 06 February 2026