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FDA biosimilars plan draws from experience with generics

Published on: 22 August 2018
Published by: Law360
  • FDA biosimilars plan draws from experience with generics
  • What is this development about?

Article summary

Law360, New York: On 11 May 2018, Donald Trump issued his blueprint to lower drug prices that describes the US administration’s plan to reduce the price of prescription drugs by, among other actions, ‘advancing biosimilars and generics to boost price competition.’ The blueprint ‘seeks to encourage innovation, while also promoting better price competition.’ To help achieve the administration’s goals, the US Food and Drug Administration recently unveiled the FDA’s Biosimilars Action Plan, which FDA Commissioner Scott Gottlieb called an important piece of the blueprint. Noting the ‘anemic’ competition for biosimilars with only three biosimilars currently marketed in the US, eleven being FDA approved at the time of the BAP release, Commissioner Gottlieb stated the BAP would help the FDA achieve the goals of ‘making the process for developing biosimilars more efficient’ and ‘promoting competition and affordability across the market for biologics and biosimilar products.’ Maria Doukas, Christopher Betti, Kathleen Sanzo, Jacqueline Berman and Michael Abernathy of  Morgan Lewis & Bockius LLP discuss the FDA’s BAP. or take a trial to read the full analysis.

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