BioCentury
ARTICLE | Product Development

U.S. biosimilars glass--half full or half empty?

Will success for biosimilars companies reduce drug price control pressure?

December 7, 2019 4:11 AM UTC
Updated on Dec 7, 2019 at 4:19 AM UTC

Ten years after the U.S. created a pathway for biosimilars--and four and a half years after the first FDA approval--a few manufacturers have demonstrated that they can overcome the technical, regulatory and commercial barriers to create sustainable businesses. Manufacturers are confident that most of the half-dozen biosimilar products on the U.S. market will be profitable and that they can launch a continuous stream of successful copies of blockbuster biologics.

Commercial success for a handful of products does not, however, mean that biosimilars will meet expectations that were unleashed a decade ago. In discussions of the technical and regulatory issues, and of legal and commercial rivalries, it is easy to forget that there is only one reason for the biosimilars pathway to exist: to reduce costs for American patients and for society...