France aims to reach 80% biosimilar penetration by 2022

Home/Policies & Legislation | Posted 26/01/2018 post-comment0 Post your comment

In the coming years France intends to promote the use of biosimilars and is aiming to reach 80% biosimilar penetration by 2022.

The statement comes as part of the country’s 2018−2022 National Health Strategy and represents an increase from the previous year’s 70% target. The National Health Strategy is the framework for health policy in France. It is defined by the French Government and outlines key policies for the country as well as possible action strategies.

France is a strong supporter of biosimilars, which it states as having the same effectiveness, quality and safety as the reference biological. In 2013, the country introduced new legislation, which, as part of a new law concerning the social security budget (pending for adoption of the decree), would allow biosimilar substitution under certain conditions: at treatment initiation and where not prohibited by the prescriber [1].

In 2017, the substitution policy was revamped, after amendment of the biosimilar substitution regime by the 2017 Social Security Financing Act. A biosimilar registry was also created by the introduction of Decree No. 2016-960. Then the National Agency for Medicines and Health Products Safety (L’Agence nationale de sécurité du médicament et des produits de santé, ANSM) introduced the first ‘similar biological groups’ in the French biosimilar register (liste de référence des groupes biologiques similaires).As of January 2018, the list contained 29 biosimilars in 11 biological reference groups.

The 2018−2022 National Health Strategy document does not specify how France intends to reach its goal of 80% biosimilars penetration by 2022. However, the publication does mention developing digital tools to aid prescribers. Also, in addition to patients starting new treatment being prescribed biosimilars rather than brand-name biologicals, the document suggests switching patients who are currently undergoing treatment to biosimilars.

Related article
Biosimilar substitution in Europe

1. GaBI Online - Generics and Biosimilars Initiative. France to allow biosimilars substitution []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 26]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Allen & Overy, ANSM,

comment icon Comments (0)
Post your comment
Related content
Panama embraces international pharmacovigilance standards
Pharmacovigilance V13F21
Home/Policies & Legislation Posted 09/07/2024
FDA proposal to remove biosimilar interchangeability status in FY25
01 AA007239
Home/Policies & Legislation Posted 12/06/2024
MHRA unveils strategy for regulating AI technologies
23 AA011020
Home/Policies & Legislation Posted 22/05/2024
Regulatory Certainty Strategy for biosimilars launched in Mexico
Home/Policies & Legislation Posted 09/04/2024
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010