Canada's approach to biosimilars questioned.

Are Biosimilars Identical to the Reference Products?

Are Biosimilars Identical to the Reference Products?

The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects

Biologic therapies have revolutionized treatment of a number of diseases. Patents and exclusivity for a number of biologics are expiring. This has created the opportunity for the development and approval of biosimilars. Biosimilars are biologic products developed using a step-wise approach to result in a biologic that demonstrates no clinically meaningful differences in terms of quality attribu...

Informed by the European Union experience: what the United States can anticipate and learn from the European Union's regulatory approach to biosimilars.

Policies for biosimilar uptake in Europe: An overview

BACKGROUND Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to cr...