On 14 July 2016, Decree No 2016-960 concerning the registration of similar biological medicinal products on the biosimilar register was published in the Official Journal. The Decree is one of the long-awaited implementing Decrees of Article 47 of the 2014 Social Security Financing Law (SSFL), which legally permits the substitution of a biosimilar for the prescribed reference biologic under certain conditions.
According to Article L. 5125-23-3 of the Public Health Code, substitution of a biosimilar is allowed only: (i) if the prescribing physician has not marked the prescription as “non-substitutable”; (ii) when initiating a course of treatment; and (iii) if both the biosimilar and reference biologic belong to the same “similar biologic group”. The Decree now defines the criteria for inclusion in a group, the procedure for registration on the biosimilar register (la liste de référence des groupes biologiques similaires) by the National Agency for Medicines and Health Products Safety (ANSM), and the content of that register.
The registration procedure is very similar to the procedure in place for generics: once a marketing authorisation for a biosimilar has been granted, the ANSM informs the marketing authorisation holder of both the biosimilar and reference biologic and registers the biosimilar on the biosimilar register (within specific time frames). The biosimilar register is grouped per reference biologic indicated by name, dosage, form, and international non-proprietary name (INN), and for each biosimilar, lists the name, dosage, form, marketing authorisation holder, therapeutic indication(s) and posology.
Biosimilar substitution is, however, only expected to occur in practice once a separate implementing Decree defines the precise conditions for biosimilar substitution by a pharmacist. Further discussions on biosimilar substitution are likely to take place during the negotiations of the upcoming 2017 SSFL.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, July 2016 Issue (Thomson Reuters).