France one step closer to biosimilar substitution: ANSM introduces first similar biologic groups
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The National Agency for Medicines and Health Products Safety (ANSM) has introduced the first "similar biologic groups" in the French biosimilar register (liste de référence des groupes biologiques similaires), pursuant to a decision dated 18 September 2017. The decision follows the amendment of the biosimilar substitution regime by the 2017 Social Security Financing Act, and the creation of the biosimilar register by Decree No. 2016-960 (See previous updates Long-awaited biosimilar register created and French Parliament approves expanding substitution of biosimilars.)
The register now contains 11 similar biologic groups, each of them defined by a reference biologic and its corresponding biosimilars listed by brand name (28 biosimilars in total). Additional information with respect to each product (such as dosage, pharmaceutical form, therapeutic indications, marketing authorisation holder and excipients with recognised action) is accessible via a link to the ANSM website.
Biosimilar substitution is legally permitted within the same "similar biologic group" provided that the physician has not marked the prescription as "non-substitutable". However, substitution is only expected to occur in practice after a separate implementing Decree that defines the precise conditions for biosimilar substitution by a pharmacist has been adopted.
In addition, on 12 October 2017, the Ministry of Health published an administrative instruction on reference biologics and biosimilars (Instruction) that underlines the essential role of biosimilars within the healthcare system. The Instruction:
- Confirms the revised framework governing interchangeability and substitution of biologics and biosimilars, as well as the applicable traceability requirements.
- Highlights challenges to the development of biosimilars (in particular, diversifying the offering of biologics so as to reduce disruption risks, obtaining solid efficiency margins and adapting hospital tender offers to favour competition by biosimilars).
- Sets out objectives to favour the uptake of biosimilars (including a 70% target to initiate treatment with a biosimilar and encouraging switching to a biosimilar during treatment) and specifies examples of actions to be taken by relevant health authorities, health facilities and local insurance bodies to help achieve the objectives (such as the provision of information brochures, campaigns and specific training, and via contracts with health facilities).
The above measures are fully in line with the draft 2018 Social Security Financing Bill, which seeks to implement incentives to support biosimilar prescribing with the aim of achieving savings for the social security system.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2017 Issue (Thomson Reuters).