Alvotech (NASDAQ: ALVO) stock soared in morning trading on Thursday after the biotech company shared an update from the U.S. FDA regarding its Biologics License Application (BLA) for AVT02 as biosimilar to Humira.
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AVT02 is a monoclonal antibody similar to Humira which is used to treat different types of arthritis including rheumatoid arthritis and psoriatic arthritis.
Alvotech stated that the U.S. FDA had granted a new Biosimilar User Fee Amendment (BsUFA) goal date of April 13, 2023, after reviewing its BLA application. However, for the application to be approved, the U.S. FDA will also reinspect Alvotech’s facility in Reykjavik, Iceland.
The company expects the Iceland facility to be reinspected in the first quarter of next year.
Robert Wessman, Founder and Executive Chairman of Alvotech commented, “We remain excited about the anticipated launch of AVT02 in the U.S. on July 1, 2023 and strongly believe that Alvotech’s interchangeable biosimilar will increase patient access in the U.S. to this important therapy.”
Shares of ALVO have slid more than 15% in the past year.
