Gillian Wollett, head of regulatory strategy and policy at Samsung Bioepis Co. Ltd., 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 Wollett.
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, Wollett said.

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