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Podcast: FDA’s Leah Christl Talks Biosimilars

 
• By Kate Rawson

US agency's Associate Director for Therapeutic Biologics Leah Christl gives the most up-to-date snapshot of biosimilar regulatory development, the potential areas for further FDA collaboration with European regulators – and how long it may be until the agency approves the first interchangeable biosimilar.

Leah Christl, head of the US FDA's biosimilar program, talks to Kate Rawson about the progress to date on applications, how her office interacts with sponsors unfamiliar with the regulatory process and the biggest hurdles companies face in biosimilar development. Here’s one surprise: sponsors are starting to use FDA/EMA’s parallel scientific advice program for biosimilars applications – most often in cases where there are differences of opinions between regulators.

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