French Parliament approves expanding substitution of biosimilars
24 December 2016
On 23 December 2016, the French Parliament adopted the 2017 French Social Security Finance Act (PLFSS). The PLFSS amended the provisions on biosimilars contained in the Public Health Code. In particular, the substitution of a biosimilar for the prescribed reference biological medicine (biologic) will be permitted not only at the start of a course of treatment, but also during, 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 amendments aim to achieve savings for the social security system. Prior to the 2017 PLFSS, French pharmacists were only permitted to substitute a prescribed reference biologic with a biosimilar at the start of treatment and if the prescribing physician had not marked the prescription as “non-substitutable”. Further, prescribing physicians were required to renew the prescription for the reference biologic and mark it as “non-substitutable, for continuity of treatment” during the course of treatment, except where the patient’s interest required otherwise.
In addition, the PLFSS requires the physician that initiates treatment with a biologic to inform the patient of the specificities of biologics and, where appropriate, substitution possibilities, and to implement clinical monitoring. This provision reflects the position taken by the National Agency for Medicines and Health Products Safety, which no longer opposes interchangeability between biologics and their biosimilars provided certain conditions are met (namely, patient’s consent, adequate clinical monitoring during treatment, and traceability of the relevant medicinal product).
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, January 2017 Issue (Thomson Reuters).