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.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in New Zealand in 2022.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe
November 16th 2023In part 3 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® reviews an analysis investigating whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars across Europe.