France · National Agency for the Safety of Medicines and Health Products · Biosimilars
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
-
Biosimilars are authorised through the EU routes. In France, a ministerial order can then allow pharmacists to substitute a biosimilar for the reference biologic within a group. Before that, the ANSM consults stakeholders and gives an opinion that can set conditions and warnings. The prescriber can exclude substitution with a justified note. After a biosimilar is authorised, for pharmacist substitution within a similar biological group.
1. Marketing authorisation; 2. ANSM consultation; 3. ANSM opinion; 4. Ministerial order.
Outcome: A ministerial order allowing substitution, with conditions set in the ANSM opinion.
Legal basis: Code de la santé publique, Article L.5125-23-2
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in France: Compassionate prescription framework (off-label use), Pharmaceutical establishment authorisation (operator, manufacturer, importer, distributor). See all routes on the France page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.