New Efforts to Encourage Biosimilar Use in Finland, Switzerland, and France

January 16, 2018
The Center for Biosimilars Staff

Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

Finnish Medicines Agency Initiates Study on Biosimilars

The Finnish Medicines Agency (Fimea) has announced that it is beginning a study to investigate factors that promote or prevent the uptake of biosimilar therapies. The study, which will be jointly funded by the Finnish Social Insurance Institution Kela and the Ministry of Social Affairs and Health, will comprise interviews of physicians who treat rheumatic diseases, inflammatory bowel disease, psoriasis, and diabetes in both university hospitals and in central hospitals across Finland. Patients who receive biologic therapies will also take part in interviews.

Fimea expects to publish the study’s results in 2019, and says that the data will provide “…support of pharmaco-political decision-making and help in promoting the implementation of rational pharmacotherapy in Finland.”

Switzerland to Allow US-Licensed Comparator Biologics in Clinical Trials

The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance concerning the use of comparator products used in clinical trials of biosimilars.

Previously, Swissmedic held that the only acceptable comparator products were those authorized in Switzerland or the European Union, though for supplementary studies (non-pivotal studies on pharmacodynamics, pharmacokinetics, and additional studies on efficacy and safety), comparator products from Japan were accepted. In its updated guidance, Swissmedic says that comparator products can now originate from the United States, and for supplementary studies, Canadian products will be allowed.

If the reference drug (the originator biologic approved in Switzerland) and the comparator products are not identical, their equivalence must be demonstrated.

Biosimilar developers will also be required to submit an Environmental Risk Assessment to Swissmedic.

France Seeks to Reach 80% Biosimilar Penetration by 2022

RAPS reports that France has committed to increasing biosimilar penetration to 80% by 2022 in its new health strategy for 2018 to 2022. According to the plan’s objective, when biosimilar products are available, 80% of patients should receive biosimilar options rather than reference biologics (a 10% increase on last year’s target numbers). The plan also encourages the non-medical switching of patients who are already receiving biologic therapy to treatment with available biosimilars.