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What’s Next? Five Things To Look Out For In January

Alvotech Waits On Pivotal FDA Inspection; JP Morgan Conference Hits San Francisco

 
• By Dean Rudge

Generics Bulletin previews the most noteworthy and anticipated events for January 2024.

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Alvotech is set to face a long-awaited US Food and Drug Administration reinspection of its Reykjavik facility in January, in a key milestone for the Icelandic firm that could pave the way finally to a US approval for its Teva-partnered AVT02 adalimumab high-concentration interchangeable biosimilar to Humira.

The FDA’s reinspection at Reykjavik has been scheduled for 10-19 January. Complete response letters issued by the agency for Alvotech’s biosimilars – including both AVT02 and its AVT04 proposed rival to Stelara (ustekinumab) – owing to manufacturing deficiencies at the facility have so far frustrated the firm’s growth ambitions. (Also see "Alvotech And Teva To Miss US Adalimumab Launch After Further FDA Setback" - Generics Bulletin, 29 June, 2023

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