Biosimilar substitution in France: no way back?

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Beginning on 1 January 2014, French pharmacists are now legally permitted to substitute a biosimilar for the prescribed (reference) biological medicine as long as the prescribing physician has not marked the prescription as ‘non-substitutable’.

According to the new law, substitution is allowed only when initiating a course of treatment and if the biosimilar belongs to the same group as the prescribed product, known as a ‘similar biologic group’. These groups will be drawn up by French healthcare authority ANSM.

However, as (i) the criteria for inclusion in a ‘similar biologic group’ by the ANSM, (ii) the procedure for registration on the biosimilar register (entitled ‘list of reference of similar biologic groups’) and the content of that list and (iii) the precise conditions for biosimilar substitution by a pharmacist remain to be further defined in decrees from the Administrative Supreme Court, biosimilar substitution should only occur in practice after these decrees have been adopted…

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