Boehringer Ingelheim’s Pagnotta Talks Adalimumab And Interchangeability
As Cyltezo Rival To Humira Hits US, Firm Says It Is ‘Uniquely Positioned’ In Biosimilars Market
• By David Wallace
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As Boehringer Ingelheim launches the first – and so far, only – interchangeable US adalimumab biosimilar, the firm’s biosimilar commercial brand lead Stephen Pagnotta talks to Generics Bulletin about how the interchangeability designation puts the firm in a unique position when it comes to competing with Humira.
Stephen Pagnotta is biosimilar commercial brand lead at Boehringer Ingelheim • Source: Boehringer Ingelheim
In an unprecedently competitive biosimilar market, only one of the several newly-launched US rivals to Humira (adalimumab) boasts a US Food and Drug Administration designation of interchangeability: Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) version. (Also see "First Interchangeable Humira Biosimilar Approved In US" - Generics Bulletin, 18 October, 2021.)
An interchangeability designation allows a pharmacist to substitute a biosimilar for its reference biologic without consulting the original prescriber, subject...
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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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