ANSM relaxes its position on interchangeability of biosimilars

On 3 May 2016, the French National Agency for Medicines and Health Products Safety (ANSM) published a new report on biosimilars, replacing its previous version dated September 2013.

The report reveals an important shift in the Agency's attitude on the interchangeability of biologics. While the ANSM previously advised against the switching of a biologic for a biosimilar (and vice versa) during the course of treatment, it no longer excludes such switching on the condition that:

• The patient consents.
• The patient receives adequate clinical monitoring during treatment.
• Traceability of the relevant medicinal products is ensured.

Indeed, the Agency considers that "in [the] light of evolving knowledge and the continuous analysis of efficacy and safety data of biosimilars within the European Union, […] a position which formally excludes all interchangeability during the course of treatment appears no longer justified". The ANSM thus joins other national authorities, such as the Dutch Medicines Evaluation Board and the Finnish agency Fimea, which relaxed their stance on biosimilar switching earlier in 2015.

The revised ANSM position, which has been submitted for validation to the General Directorate of Health, may stimulate the on-going debate on biosimilar substitution in France. Since January 2014, French pharmacists have been legally permitted to substitute a biosimilar for the prescribed reference biological medicinal product at the initiation of treatment and if the prescribing physician has not marked the prescription as "non-substitutable", though the implementing decrees that must define the precise conditions for such substitution remain to be adopted.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, May 2016 Issue (Thomson Reuters).