Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations
FDA acceptance of AVT80 BLA adds subcutaneous Entyvio biosimilar, expanding regulatory pipeline.
What changed
FDA acceptance of AVT80 BLA adds subcutaneous Entyvio biosimilar, expanding regulatory pipeline.
Why it matters
FDA acceptance of AVT80 BLA adds subcutaneous Entyvio biosimilar, expanding regulatory pipeline. — impact context not separately stored; see What changed.
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Aug 31, 2026 10:12 AM ET