French Parliament debates on expanding substitution of biosimilars
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The 2017 French Social Security Finance Bill (PLFSS), currently under discussion in the French Parliament, amends the regulatory provisions on biosimilars set out in the Public Health Code with the aim of allowing their substitution also during the course of treatment and thus achieving savings for the national health insurance. Since January 2014, French pharmacists have been legally permitted to substitute a biosimilar for the prescribed reference biological medicinal product (biologic) under certain conditions, namely: (i) at the initiation of treatment, (ii) if the prescribing physician has not marked the prescription as “non-substitutable”, and (iii) if both the biosimilar and reference biologic belong to the same “similar biologic group”. During the course of treatment, prescribing physicians must renew the prescription for the same reference biologic and mark it as “non-substitutable, for continuity of treatment”, except where the patient's interest requires otherwise. If the PLFSS is approved as it stands, substitution of a biosimilar for the prescribed reference biologic will be permitted both at the initiation and during the course of treatment provided the physician has not marked the prescription as “non-substitutable” (similarly to generics). It will thus be up to the physician to decide whether a biologic can be substituted during the course of treatment.
The Explanatory Memorandum highlights the shift in the National Agency for Medicines and Health Products Safety (ANSM)’s attitude toward the interchangeability of biologics. As reflected in the Agency’s report on biosimilars of May 2016, the ANSM no longer opposes the interchangeability between biologics and their biosimilars during the course of treatment provided certain conditions are met (the patient consents, receives adequate clinical monitoring during treatment, and traceability of the relevant medicinal products is ensured).
Biosimilar substitution is, however, only expected to occur in practice once a separate implementing Decree defining the precise conditions for biosimilar substitution by a pharmacist is enacted.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, October 2016 Issue (Thomson Reuters).