Venable·FDA / LIFE SCIENCES REGULATORY

FDA Accepts Second Interchangeable Vedolizumab aBLA From Alvotech and Teva

The agency will review a subcutaneous AVT80 filing as the Entyvio biosimilar race accelerates alongside pending BPCIA litigation over Takeda's reference product.

vedolizumabbiosimilarinterchangeablealvotechtevaentyviobpciafda-acceptance
Read the original firm alert → Saturday, September 5, 2026

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