Biosimilars are now established in Europe and have been approved in highly regulated markets throughout the world, including the approval and launch of the first biosimilar in the United States in 2015. While the science is the same everywhere, laws governing biosimilar approval vary in each country, which impacts regulators' behavior. The biosimilar development process relies primarily on in-depth analytical studies comparing the biosimilar candidate to its reference product, substantially reducing the need for extensive clinical studies. However, the need for a local reference product and the different types of clinical studies sought by different regulators can still create challenges for biosimilar sponsors which, just like originator sponsors, are trying to launch products in as many markets as possible. Nonetheless, many of the principles governing the development and approval of biosimilars are consistent across markets.
In this paper, Avalere experts explore the development process and approval decisions for four classes of products—somatropins, filgrastims, epoetins, and infliximabs—that were approved in different jurisdictions. Results consider how global versus regional considerations for biosimilars have an impact on approval.
Read the full paper here.