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...
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