November 6, 2019 – Gatineau, Quebec – The Alliance for Safe Biologic Medicines (ASBM) today released an abstract from a forthcoming white paper that provides a comprehensive overview of the evolution of the European biosimilars market.  The abstract was released in conjunction with the Drug Information Association (DIA) Annual Canadian Meeting, an annual meeting of Canadian health regulators and pharmaceutical manufacturers, held this year in Gatineau, Quebec. The full whitepaper will be published in the Journal of the Generics and Biosimilars Initiative (GaBI Journal) later this month.

As the world leader in biosimilar approval and commercialization, Europe comprises more than half of the global biosimilar market with more than 60 approved biosimilars. Average biosimilar uptake rates across European countries is 43% for complex biosimilars such as monoclonal antibodies, first approved in 2013. For older biosimilars approved before 2013 the average market share is 91%, according to the whitepaper. From the abstract:

“European countries, with their diverse healthcare systems and their experience to date, serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market, and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.”

In the vast majority of European countries, the payer reimburses multiple products, including the originator. This ensures a sustainable biosimilar market with multiple suppliers competing in a given product class. Even in Norway with its national tender system, physicians retain the option to prescribe any of the available products but are strongly encouraged to choose the lowest priced product, in particular for newly treated patients.

ASBM Executive Director, Michael Reilly expressed his hope that the white paper will serve as an educational resource for countries outside of Europe seeking to build robust and sustainable biosimilars programs and policies for their patients that are similar to those found across European Union Member States.