Streamlining Biosimilars: Navigating Regulation and Interchangeability

Gillian Woollett, head of regulatory strategy and policy at Samsung Bioepis, discusses how FDA can deliver on its promise to “massively streamline” the regulation of biosimilars. Eliminating unnecessary clinical trial requirements could halve the time and cost of developing a biosimilar, according to Woollett.
While regulators around the world are converging on ideas that will slash development times, commercial challenges, especially in the U.S., are far more challenging. The Medicare Drug Price Negotiation Program has undermined the economic rationale for investing in biosimilars. President Donald Trump’s proposals for most favored nation pricing would “kill” the industry, Woollett said.

View full story: https://www.biocentury.com/article/656445

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00:00 - Introduction
02:50 - Halving the Time and Cost
10:30 - Interchangeability
15:50 - The Importance of Market Share
22:08 - Most Favored Nation