- Trial Phase
- Filed/BLA under FDA review
- Time to Market
- If approved, AVT80 could launch in the US in the second half of 2027, assuming a standard 10-month BLA review from the August 2026 acceptance date.
- Why 6/10
- AVT80's BLA was accepted for FDA review on August 31, 2026. A standard 10-month review would set a PDUFA goal date around June 2027, which is roughly 7 months from now. This is a major value driver for Alvotech, but the company also has other pipeline programs (AVT16, AVT02/SIMLANDI) so it is not a pure single-asset binary.
Watch for the FDA's PDUFA goal date for AVT80, likely around mid-2027. The stock also has other catalysts: AVT16 (IV vedolizumab biosimilar) and AVT23 decisions could come sooner. Alvotech reported Q3 earnings on November 11, 2026, which may provide pipeline timeline updates. The Barclays upgrade to Overweight with an $8 price target (vs ~$4.88 recent price) highlights the risk-reward into these FDA decisions.
Price Chart
Executive Summary
AVT80 is Alvotech's proposed interchangeable biosimilar to Takeda's Entyvio (vedolizumab), developed as a subcutaneous injection for ulcerative colitis and Crohn's disease. A pivotal pharmacokinetic study met all primary endpoints in February 2026, and the FDA accepted the BLA for review on August 31, 2026. With a standard 10-month review cycle, a decision is expected around mid-2027. Alvotech has multiple FDA decisions pending in its pipeline, and analyst consensus is bullish (11 Buy/Strong Buy vs 2 Hold), with a mean price target of $7.20 implying ~47% upside from the recent $4.88 close. However, the company faces risks including potential US import tariffs on its Iceland-manufactured products, ongoing profitability challenges, and competition from other Entyvio biosimilars.
How It Works
AVT80 is a biosimilar version of vedolizumab (Entyvio), a drug used to treat inflammatory bowel diseases like ulcerative colitis and Crohn's disease. Vedolizumab works by blocking a protein on immune cells called alpha4-beta7 integrin, preventing those cells from entering the gut lining and causing inflammation. As a biosimilar, AVT80 is designed to be highly similar to the original brand-name drug and interchangeable with it at the pharmacy level. The subcutaneous version (AVT80) can be injected under the skin, while the IV version (AVT16) is given as an infusion.
Trial Status
AVT80 is a proposed interchangeable biosimilar to Entyvio (vedolizumab) for subcutaneous administration via prefilled syringe and autoinjector. A pivotal pharmacokinetic study met all primary endpoints in February 2026, comparing AVT80 to Entyvio in healthy adults. The FDA accepted the BLA for review on August 31, 2026. AVT80 complements AVT16, Alvotech's IV formulation of the same biosimilar, whose BLA was accepted in May 2026.
The Two-Sided Case
Upcoming Catalysts
- FDA decision on AVT80 BLA (estimated PDUFA around mid-2027)
- FDA decision on AVT16 (IV vedolizumab biosimilar, BLA accepted May 2026)
- FDA decision on AVT23 (another biosimilar program, also targeted for Q4 2026 per company guidance)
- Q3 2026 earnings readout (reported November 11, 2026) may provide pipeline and timeline updates
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Alvotech PRESS-RELEASE ALVO ·Originating report