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Teva: Amgen’s Interchangeable Humira Biosimilar Too Late For January 2023

Israeli Firm Commits To Debt Repayment And Rules Out High-Cash Deals

 
• By Dean Rudge

Teva discussed its proposed rivals in the US biosimilar adalimumab space, biosimilar business development plans and prioritizing debt during its Q3 earnings call. The Israeli firm’s revenues succumbed to challenges in the US generics space.

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Teva has weighed in on rival Amgen's biosimilar Humira candidate • Source: Alamy

Teva predicts Humira (adalimumab) biosimilar rival Amgen will not receive a US Food and Drug Administration designation for interchangeability for its Amjevita (adalimumab-atto) version in time for the US-based firm’s agreed launch date in January 2023.

Last month, Teva’s Humira biosimilar partner Alvotech saw a delay in FDA action on its AVT02 biosimilar candidate, a proposed rival to the higher-concentration formulation, after obstacles preventing facility inspections led the agency to defer action on the firm’s biologics license application

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