The U.S. Food and Drug Administration has accepted for review a Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to vedolizumab (Takeda’s Entyvio), Alvotech said on June 8. Under the partnership, Alvotech handles development and manufacturing, while Teva Pharmaceutical Industries is responsible for commercialization in the United States.
Vedolizumab is an integrin receptor antagonist that binds the α4β7 integrin to blunt the migration of white blood cells into gut tissue. It is approved for adults with moderately to severely active ulcerative colitis and Crohn’s disease. AVT16 is being developed as a lyophilized vial for intravenous infusion.
What acceptance does — and doesn’t — establish
Acceptance starts the FDA’s review clock; it is not approval. Alvotech says the filing rests on “analytical, pharmacokinetic, and immunogenicity data” to support biosimilarity. Notably, the company states that the pivotal clinical study tested a different molecule: a randomized, double-blind, single-dose, parallel-group, three-arm trial of AVT80 — a subcutaneous candidate — against vedolizumab in healthy adults, which “met all its primary endpoints.” On regulatory advice, that trial is being used to support clinical similarity for both AVT16 and AVT80.
“Biosimilarity and interchangeability have not been established by regulatory authorities and are not claimed,” the company’s release states.
Two cautions for readers. The press release reports no participant counts, no pharmacokinetic confidence intervals, and no target action date, so those numbers cannot be printed here. And the interchangeability designation — which would permit pharmacy-level substitution without prescriber sign-off — remains a request, not a ruling. In the European Union, the European Medicines Agency has validated a marketing application covering both AVT16 and AVT80.