Global biotechnology company Alvotech S.A. (NASDAQ:ALVO) announced on Monday that the US Food and Drug Administration (FDA) has accepted for review its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) lyophilised vial for intravenous administration.

Under its partnership with Teva Pharmaceutical Industries (NYSE:TEVA; TASE:TEVA), Alvotech is responsible for the development and manufacturing of AVT16, while Teva will commercialise the product.

The application is supported by analytical, pharmacokinetic and immunogenicity data intended to demonstrate biosimilarity between AVT16 and the reference product.

If approved, AVT16 could be substituted for Entyvio at the pharmacy level in the United States, subject to applicable laws, without prescriber intervention.

The filing follows positive results reported in February 2026 from a pivotal pharmacokinetic study of AVT80, Alvotech's proposed subcutaneous biosimilar to Entyvio, which met all primary endpoints. According to regulatory guidance, the study is considered pivotal for demonstrating clinical similarity for both AVT16 and AVT80.

In the European Union, the European Medicines Agency has validated a marketing authorisation application covering both AVT16 (lyophilised vial) and AVT80 (pre-filled syringe and auto-injector), although neither product has yet received regulatory approval in any market.