Nordic Patient Groups Tackle Biosimilar Policy Issues
October 13, 2016
Biosimilar medicines are being prescribed more and more freely across Europe. But access to, and use of, these new medicines differs greatly depending on which European country you live in. A recent workshop by the Global Alliance for Patient Access allowed patient advocates from across Europe’s Nordic region to explore these challenges, consider biosimilar policies and discuss a topic of growing international interest: switching.
Discussion about the naming of biological medicines, the extrapolation of approved uses, immunogenicity and the effects of switching engaged the group, which included advocates from Sweden, Denmark and Iceland. Patient representatives considered these policies’ implications for patients in the fields they represented: gastroenterology, rheumatology and dermatology.
While each patient group brought its own stories and experiences, one issue in particular drove active discussion. Dialogue on the new NOR-SWITCH study, whose results will be presented at next week’s United European Gastroenterology Week in Vienna, invited insight and questions about switching stable patients from a biologic to a lower-cost biosimilar. The subject was the topic of a June GAfPA meeting and a recent GAfPA white paper.
Though biosimilars have already proven themselves in Europe as a valuable way to expand options for patients, little data exists about the safety and impact of switching patients from a biologic to a biosimilar. GAfPA’s white paper warns policymakers against letting the eagerness for cost savings bring them to exaggerate or misinterpret the NOR-SWITCH study’s results. (The study tests only a single switch from a biologic infliximab to a biosimilar version for patients with inflammatory diseases.)
Meeting participants agreed that patients and physicians should have a say in the decision-making process regarding biologic and biosimilar treatments – and that stable patients should have a choice about switching to a biosimilar medicine.
For more on the NOR-SWITCH study, read “NOR-SWITCH: What will Norway’s infliximab switching study tell us about the safety of switching patients from one biologic medicine to a biosimilar?”.Tags: Biologics, Regulatory Issues
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