Alvotech's AVT80 BLA Accepted by FDA for Subcutaneous Entyvio Biosimilar

โดย Yahoo Finance·US·Read original
Summary · why it matters

Alvotech announced that the U.S. Food and Drug Administration has accepted for review its Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for subcutaneous administration via prefilled syringe and autoinjector. This acceptance follows the May acceptance of Alvotech's BLA for AVT16, the intravenous presentation, meaning the company's vedolizumab biosimilar program now covers both intravenous and subcutaneous forms. Under a partnership with Teva Pharmaceutical Industries, Alvotech handles development and manufacturing while Teva manages commercialization. The BLA is supported by analytical, pharmacokinetic, and immunogenicity data, and a pivotal pharmacokinetic study met all primary endpoints in February 2026. If approved, AVT80 would expand biosimilar options for patients with ulcerative colitis and Crohn's disease in the United States.

Impact on assets 2

Biotech & Genomic Medicine▲ · 1 stocks
Alvotech
ALVO
▲ PositiveRegulationrelevance

FDA acceptance of BLA for AVT80, a key regulatory milestone for the biosimilar.

Health Care▲ · 1 stocks
Teva Pharma Industries Ltd ADR
TEVA
▲ PositiveRegulationrelevance

Teva commercializes Alvotech's vedolizumab biosimilars, so the FDA acceptance of the AVT80 BLA advances a partnered product Teva will sell.

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