Shots:
- The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev. active ulcerative colitis & Crohn’s disease
- BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity between AVT16 & the reference product, plus Alvotech has filed a request for an interchangeable biosimilar designation
- In Feb 2026, Alvotech reported results from a PK study of AVT80, a SC biosimilar to Entyvio, which met all 1EPs in healthy adults. Based on regulatory guidance, the study is considered pivotal for demonstrating clinical similarity for both AVT80 & AVT16 (both under EMA’s review)
Ref: Globenewswire | Image: Alvotech | Press Release
Related News: Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)
PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com
