Shots:
- The US FDA has accepted a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) PFS & autoinjector for SC administration
- BLA was backed by analytical, PK & immunogenicity data, showing biosimilarity with the reference product. Plus, under a partnership with Teva, Alvotech is responsible for development & manufacturing of AVT80, while Teva will handle its commercialization
- In Feb 2026, Alvotech reported positive pivotal PK study results for AVT80, which met all 1EP vs Entyvio in healthy adults, with regulators considering the study pivotal for demonstrating clinical similarity of AVT16 (Biosimilar, Entyvio IV) & AVT80
Ref: Globenewswire | Image: Alvotech | Press Release
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