Frontrunner Amgen Expects US Biosimilars To ‘Shift Significantly’ With Adalimumab

Firm Prepares To Launch First Humira Biosimilar At A ‘Pivotal Time’ For The US Market

Amgen expects a significant shift in the US biosimilars landscape as Humira rivals launch next year, Chad Pettit, the firm’s executive director of marketing and global biosimilars lead, tells Generics Bulletin. The company expects to be first to market with its version of adalimumab from the end of January 2023, helping to drive long-term growth ambitions for its biosimilars business.

Paradigm Shift Sign
Humira biosimilars will shift the US market significantly • Source: Shutterstock

The advent of biosimilar competition to Humira (adalimumab) will mark a significant shift in the US biosimilars market, Amgen believes, as the firm prepares to lead the charge with a late January 2023 launch of its Amjevita (adalimumab-atto) version.

In the second part of an exclusive interview with Generics Bulletin, Amgen executive director of marketing and global biosimilars lead...

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US Biosimilars

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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