Objectives: To provide an overview of biosimilars uptake in Europe and assess policies and initiatives that might boost uptakes of biosimilars in European countries. Methods: A literature review was conducted from European and national health authorities websites, Generics and Biosimilars Initiative (GaBi) website, Medline® database, and available grey literature. Results: To date, 17 biosimilars were granted marketing authorization throughout the European Union and the European Medicines Agency released 9 product-specific biosimilar guidelines. Recent approval of the first monoclonal antibody biosimilar of infliximab demonstrates the evolution of the European regulatory framework over time allowing approval of structurally complex molecules. Despite Europe has been a pioneer in this regulatory path, biosimilars uptake still remains limited (about 30% to 50% volume uptake) with modest price discounts from the originators (15% to 30%). If Germany authorized substitution of biological products produced by a same manufacturer in 2011, none of the Members States had allowed substitution of biological products from different manufacturers so far. With adoption of the 2014 social security funding law, France is becoming the first country to allow biosimilars substitution when initiating treatment course. To encourage biosimilars substitution, the Norwegian Medicines Agency announced in 2013 the funding of clinical studies with infliximab originator and biosimilars in which patients would be switched from originator to biosimilars forth and back. Moreover, increased price discounts of about 40% were applied for infliximab in Norway. By 2020, expected savings for biosimilars are estimated around € 12-33 billion in big EU5, Poland, Romania, Sweden. Conclusions: While patent cliff of major biologic drugs is expected on the next 5 years, initiatives to reassure physicians to prescribe biosimilars and implementation of substitution rules, even if still raising some reluctance, might contribute to boost biosimilar uptake in Europe. Price competition will impose manufacturers of branded biologics to adopt new pricing strategies.
Young, K. E., Rémuzat, C., Urbinati, D., & Toumi, M. (2014). Boosting Biosimilars Uptake in European Countries. Value in Health, 17(7), A408–A409. https://doi.org/10.1016/j.jval.2014.08.958