Alvotech Stock Gains After FDA Accepts for Review Crohn's Treatment AVT80

Dow Jones00:56

Shares of Alvotech rose after the Food and Drug Administration accepted for review a biologics license application for a potential biosimilar for an ulcerative colitis and Crohn's disease treatment.

The stock rose 4.8% to $5.19 on Monday. Shares are up 1.2% year to date.

Alvotech said the application is for AVT80, a proposed interchangeable biosimilar to prefilled syringe and autoinjector forms of Entyvio.

Entyvio, which is a trademark of Takeda Pharmaceuticals' Millennium Pharmaceuticals unit, is approved to treat adults with moderately to severely active ulcerative colitis and Crohn's disease.

In the U.S., pharmacies can substitute interchangeable biosimilars for the reference product without the intervention of the prescriber.

Alvotech is responsible for developing and manufacturing AVT80, while Teva Pharmaceutical Industries is responsible for commercialization.

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