8 April 2019 - Biopharmaceutical products (also known as biologics) are among the most expensive pharmaceutical products on the market, and their share in drug spending continues to grow. 

Seeking to increase patient access to biologics and mitigate their growing share in health care spending, policy makers have created pathways for approval of follow-on versions of original biologics known as “biosimilars.” As part of these efforts, last July, the FDA announced a Biosimilar Action Plan (BAP) which aims to “more efficiently manage [FDA] review and licensure pathways to facilitate biosimilar competition” in light of what the FDA recognizes is a biosimilars market that is “still maturing.” 

However, some commentators and industry observers believe that competition is soon coming as a “wave of biosimilars” is about to sweep over pharmaceutical markets, bringing with it an “explosion” of follow-on versions of these often life-saving products. Biosimilar developers and investors are therefore optimistic about prospects of growth in biologics markets and increasing revenues.

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