National Health Insurance (Assurance Maladie, AM) has published pharmacist guidance on biosimilar dispensing and substitution, setting out the payment rules that will apply when France extends its ‘third-party payment against generics’ mechanism to substitutable biosimilars.
The guidance follows the 10 April 2026 order that widened pharmacist substitution to 11 biological molecules. That order expanded the legal scope of substitution. The June AM guidance focuses on how the rule will operate in pharmacy practice and how refusal of substitution will affect payment from 1 September 2026.
Substitution remains limited to medicines within the same biosimilar group. It is also excluded where the prescriber has used the required justified wording to prevent substitution. AM also restates practical dispensing conditions, including patient information, traceability and attention to administration devices where relevant.
From 1 September, third-party payment will normally depend on acceptance of substitution when a substitutable biosimilar is available. Where the insured person refuses substitution, they will generally have to pay the full amount at the pharmacy and then seek reimbursement afterwards.
The reimbursement basis may also change. AM states that reimbursement may, depending on the case, be calculated by reference to the most expensive biosimilar in the group. Third-party payment remains available where non-substitution has been justified by the prescriber, or where the reference biological medicine is priced no higher than the biosimilar.
The June guidance gives the April substitution expansion its practical payment setting. France is using pharmacy substitution and third-party payment together, making patient refusal of biosimilar substitution a direct point in the reimbursement flow rather than only a dispensing choice.
Source: National Health Insurance, AM
Link: Règles de dispensation et substitution des médicaments biologiques (de référence ou biosimilaires) (Rules for dispensing and substitution of biological medicines, whether reference or biosimilar medicines)
Date: 26 June 2026
