Principle of Automatic Substitution by Biosimilars

Like generic medicines, biological medicines that are very similar to another biological medicine (biosimilars) are included in a list drawn up by the French National Agency for the Safety of Medicines and Health Products (ANSM), which specifies the reference biological medicine and the biosimilars belonging to each group. However, substitution in pharmacies is not automatic and is subject to stricter rules than for generics.

In accordance with the legal provisions in force, physicians may decide to prescribe either the reference biological medicine or its biosimilar, either at the beginning or during the treatment of their patients, after duly informing them. For the time being, only two reference biological medicines may be substituted by pharmacists.

The Social Security Financing Act (SSFA) for 2024 introduced a new provision aimed at encouraging the substitution of biosimilars, which represents a major cost-saving lever for the health insurance system, through the principle of automatic inclusion in the list of similar biological groups that can be substituted by dispensing pharmacists[1].

This measure provides that two years after the registration for reimbursement of the first biosimilar in a given group, a decree of the Minister of Health will allow substitution by pharmacists within this group, unless ANSM issues an opinion to the contrary before the end of this two-year period. If ANSM’s opinion is not opposed to substitution, it may, if appropriate, include conditions for substitution and patient information.

For biosimilars already approved for reimbursement before the publication of the SSFA, ANSM will have to issue an opinion before 31 December 2024.

In order to implement this new measure, ANSM recently announced the creation of a temporary scientific committee (TSC) entitled “conditions for implementing the substitution of similar biological medicines[2]. The TSC, made up of representatives of patient associations and healthcare professionals, will be responsible for carrying out preliminary work before ANSM issues its opinion. The preliminary work conducted by the TSC will aim to define the conditions under which pharmacists will be authorised to substitute biosimilars.


[1] Article 54 of Law no. 2023-1250 of 26 December 2023 on the financing of social security for 2024, supplementing article L. 5125-23-2 of the French public health code.


Written by
Johanna Harelimana
Johanna Harelimana
I am a junior associate, with experience advising clients on regulatory matters across several sectors, especially in life sciences, food and beverages, and environmental sectors. I currently offer both French and international clients legal advice on product's qualification, clinical trials, market access, price and reimbursement, anti-gift regulation, advertising and promotion, e-health (including telemedicine), as well as drafting contracts (distribution, professional services, clinical trial agreements, etc). I also assist with regulatory advice on other products such as cosmetics, biocide, phytopharmaceuticals and novel food.
Caroline Arrighi-Savoie
Caroline Arrighi-Savoie
As a senior associate in the Commercial group, I am specifically in charge of healthcare and life sciences issues.

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