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Alvotech announces FDA acceptance for review of Biologics License Application for AVT80 ...
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Fusion42 · 31 August 2026 · Fusion42 review
Alvotech's Biologics License Application (BLA) for AVT80, an interchangeable biosimilar to Entyvio for subcutaneous use, has been accepted for FDA review, expanding its biosimilar program alongside AVT16 for intravenous administration. AVT80 aims to increase biosimilar options for inflammatory bowel disease treatment in the U.S., with commercialization in partnership with Teva Pharmaceutical.
This Wire brief sits within Fusion42's coverage of Biotech.
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You now have a clear sign that biosimilars for inflammatory bowel disease will soon include interchangeable subcutaneous options, creating a new path for patient access and pharmacy substitution without prescriber intervention. Early moves to align with or support Teva’s commercial rollout could speed your entry into rheumatology or gastroenterology biosimilar supply chains.
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1 source · 31 Aug 2026
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