REG-Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio®
Alvotech announced that the FDA has accepted for review its Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab). AVT16 is being developed for intravenous administration under a partnership with Teva Pharmaceutical, which holds commercialization rights. The submission is supported by comprehensive analytical, pharmacokinetic, and immunogenicity data. This follows positive pivotal PK study results for AVT80 (subcutaneous Entyvio biosimilar) in February 2026.
Key figures
- Drug Name
- AVT16
- Phase Of Trial
- BLA submission
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