Legislation published in the Journal Officiel on 14th April 2022 establishes a first list of similar biological groups authorised for substitution by pharmacists. Two groups feature on the list, namely:
- Filgrastim (reference biologic Neupogen; biosimilars Accofil, Nivestim, Tevagrastim, Zarzio)
- Pegfilgrastim (reference biologic Neulasta; biosimilars Cegphila, Fulphila, Nyvepria, Pelgraz, Pelmeg, Ziextenzo)
Pharmacists are able to switch a biological drug for a biosimilar version provided that the two drugs are included in the same group of similar biological drugs and the prescriber has not expressly prohibited substitution on the script. Pharmacists are required to inform the prescriber and patient of the switch.
Provision for pharmacy-level substitution of biological drugs with biosimilar versions is included in the Public Health Code (in line with a corresponding provision in the 2022 Social Security Finance Law) but had not been possible in practice in the absence of a list of similar biological groups.
Sources:
- www.vidal.fr, “Substitution de biosimilaires par le pharmacien d’officine : feu vert pour le filgrastim et le pegfilgrastim”, 20th April 2022
- www.lemoniteurdespharmacies.fr, “’Substitution’ des biosimilaires: cet arrêté qui crée la surprise”, 14th April 2022
- www.village-justice.com, “Substitution des medicaments biologiques similaires par les pharmaciens, retour vers le futur?”, 8th March 2022