France has expanded the list of biosimilar groups that may be substituted in community pharmacy, broadening one of the practical levers used to increase biosimilar use beyond prescriber-led switching. The change is a limited implementation update rather than a new biosimilar policy, but it extends substitution into additional high-value biological markets.
The Minister of Health, Families, Autonomy and Disabled People and the Minister for Public Action and Accounts issued the Arrêté du 10 avril 2026 modifiant l’arrêté du 20 février 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 (Order of 10 April 2026 amending the order of 20 February 2025 setting the list of similar biological groups substitutable by community pharmacists and the related conditions for informing prescribers and patients). The order was published in the Journal officiel de la République française on 14 April 2026.
The order replaces the annex to the February 2025 framework. It now sets 11 substitutable biosimilar groups: filgrastim, pegfilgrastim, ranibizumab, teriparatide, etanercept, adalimumab, enoxaparin, follitropin alfa, epoetin, aflibercept and ustekinumab.
The conditions remain closely defined. Prescribers must inform patients that substitution may occur. Pharmacists must inform patients when substitution takes place, identify the dispensed medicine on the prescription, notify the prescriber, record the medicine and batch number, and seek continuity of dispensing at later pharmacy visits.
The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) made a separate reference-list update on 22 April 2026, adding denosumab biosimilars under Prolia and Xgeva and the ustekinumab biosimilar Usgena under Stelara. The decision does not extend pharmacist substitution by itself, but it keeps the biosimilar grouping framework aligned with recent market entries after the April substitution order.
The addition of ustekinumab is commercially relevant because it brings pharmacy substitution into a biologic market where biosimilar competition is still developing. The annex adds specific safeguards around device choice, patient support and authorised indications. It also notes that Stelara and its biosimilars may not have identical marketing authorisation scopes, including for paediatric Crohn’s disease and ulcerative colitis. Substitution is therefore possible only within the authorised indications of the dispensed product.
The revised list gives biosimilar competitors a wider retail-pharmacy route to uptake. Originator manufacturers face a broader substitution mechanism, although device familiarity, patient continuity and indication differences may still affect the pace of erosion.
Source 1: Légifrance
Link: Arrêté du 10 avril 2026 modifiant l’arrêté du 20 février 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 (Order of 10 April 2026 amending the order of 20 February 2025 setting the list of similar biological groups substitutable by community pharmacists and the related conditions for informing prescribers and patients)
Date: 14 April 2026
Source 2: National Agency for the Safety of Medicines and Health Products
Link: Décision du 22/04/2026 portant modification de la liste de référence des groupes biologiques similaires mentionnée à l'article R. 5121-9-1 du code de la santé publique (Decision of 22 April 2026 amending the reference list of biosimilar groups mentioned in Article R. 5121-9-1 of the Public Health Code)
Date: 22 April 2026
