In more detail
A biologic drug is a susbtance produced from or derived from a living cell or organism. Biological drugs include many vaccines, antibodies and growth hormones.
Pursuant to article L. 5121-1 of the French Public Health Code, a biosimilar drug is a biological drug with the same qualitative and quantitative composition in active substance and the same pharmaceutical form as a reference biological drug, but which does not meet the conditions for being considered as a generic speciality due to differences linked in particular to the variability of the raw material or the manufacturing processes and requiring the production of additional preclinical and clinical data.
Indeed, given their more complex structure, biological molecules cannot be manufactured in strictly identical copies, as is normally the case with molecules of chemical origin.
Biosimilar drugs are authorized under strict conditions to ensure patient safety.
The development of biosimilar drugs has several interests, in particular, to diversify the supply of biological medicines and thus reduce the risk of shortages and to allow savings by taking advantage of the fact that many patents for biological drugs have been placed in the public domain. The price of biosimilars drugs would be 15 to 30% lower than that of reference biological drugs.
In order to encourage the use of biosimilar drugs in France, the Social Security Financing Act for 2014 introduced a provision allowing pharmacists to substitute biosimilar drugs, under certain conditions. However, in practice, this measure has never been effective as the implementing decree was never published by the French government due to some difficulties related to traceability.
Various incentive measures (particularly in hospitals) have been adopted since then, in order to strengthen the use of biosimilar drugs in France. A large number of stakeholders further stressed the need to stimulate the development of these medicines, particularly outside hospitals.
The aim of the Social Security Financing Act for 2022 was therefore to re-establish the possibility for pharmacists to substitute biosimilars drugs, under strict conditions, that are recalled in ANSM's report.
In order to ensure proper use and safety during substitution, ANSM proposes a progressive implementation of substitution, in several phases, firstly targeting a limited but representative number of biological drugs. According to ANSM, this will allow healthcare professionals to familiarise themselves with the conditions of substitution and to reinforce their knowledge of biological medicines, the final objective being to ensure patient support and safety.
The first two groups of substitutable biosimilars were published by ministerial decree on 12 April 2022, following ANSM's opinion. These are fligrastim and pegfilgrastim.