Incentives for market penetration of biosimilars in Belgium and in five European countries.

Abstract

Biosimilars are products similar to a biological already authorized and no longer protected by a patent. As the biological product, they contain a biological substance produced by or derived from a living organism. Alike with generics, biosimilars are potential tool to ensure savings for health systems. The current lack of market penetration of biosimilars may be seen by national authorities as a lost opportunity in terms of cost- containment. The objective of this paper is therefore to analyze the current situation in Belgium and to identify potential measures to stimulate biosimilar uptake in Belgium through an analysis of the experience in five European countries: France, Germany, The Netherlands, Spain and Sweden. This international comparison was performed using a two steps analysis: a structured review of the literature followed by a validation from experts in each country. Potential incentives and constraints were identified, i.e., prescription quotas/target, clinical guidelines, primary substitution, reference price system, fixed payment and public tendering. However, the literature reviewed provided little evaluation of the effectiveness of these policies in terms of biosimilar uptake or potential savings. The impact of these policies on biosimilar related savings is currently based on expectation and assumptions. Such kind of studies is therefore essential in the future.