AmerisourceBergen Sees Momentum Build In US Biosimilars

Key Developments Around Insulins And Interchangeability Slated For 2021

AmerisourceBergen’s senior director of biosimilars, Sean McGowan, believes that momentum is continuing to build for US biosimilars in 2021, especially with key developments involving insulins and interchangeability on the horizon.

Amerisource_Bergen
AmerisourceBergen sets out its vision for US biosimilars in 2021 • Source: Shutterstock

This year is expected to be another significant one for the US biosimilars market as momentum builds and a “second wave” of investment in biosimilars materializes, at the same time as biosimilar insulins begin to reach the market, AmerisourceBergen’s senior director of biosimilars, Sean McGowan, tells Generics Bulletin in an exclusive Q&A.

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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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