JUN 30 2027
Alvotech — Entyvio (vedolizumab) $ALVO
for moderately to severely active ulcerative colitis and Crohn's disease, adults (proposed biosimilar, subcutaneous prefilled syringe and autoinjector)
Accepted AUG 31 2026.
About
Ulcerative colitis and Crohn's disease are chronic inflammatory bowel diseases that cause abdominal pain, severe diarrhea, and fatigue. Entyvio is an antibody that specifically blocks a protein on certain immune cells, preventing them from entering the gut lining. This targeted action may reduce inflammation in the digestive tract while leaving the rest of the body's immune defenses largely intact.
Drug Watch — recent news on Entyvio
- Five biosimilar manufacturers attack Millenium’s Entyvio patents in London - JUVE Patent
- FDA to review Alvotech (Nasdaq: ALVO) subcutaneous Entyvio biosimilar - Stock Titan
- Fresenius Kabi's Vedolizumab Biosimilar Clears FDA and EMA Review Milestone - BioPharma APAC
- Polpharma Biologics’ Entyvio biosimilar accepted for FDA, EMA review - The Pharma Letter
- Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate - STT Info
Sponsor Watch — recent news on Alvotech
- Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations
- Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio® to Subcutaneous Presentations
- Alvotech Announces Licensing and Commercialization Agreement with Lotus Pharmaceutical for proposed biosimilars to durvalumab and emicizumab in the U.S. and Selected Asian Markets
- Alvotech (ALVO) Reports Q2 Loss, Beats Revenue Estimates
- Alvotech Announces Financial Results for the First Half of 2026 and Provides a Business Update