Alvotech (NASDAQ:ALVO) shares climbed 12% in premarket trading on Thursday after the biotechnology company announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for AVT16, an interchangeable biosimilar candidate to Entyvio.
The regulatory development represents an important step forward for Alvotech as it advances plans to compete in the market for biosimilar versions of the inflammatory bowel disease treatment.
FDA review advances AVT16 toward potential approval
According to the company, AVT16 is being developed as an interchangeable biosimilar to Entyvio, a biologic medicine widely used to treat inflammatory bowel diseases.
FDA acceptance of the application means the agency will now proceed with a formal review of the product, moving Alvotech closer to a potential commercial launch in the United States.
The Iceland-based biopharmaceutical group said that, if approved, AVT16 could be substituted for Entyvio at pharmacies without prescriber intervention.
Interchangeable status could broaden market opportunity
An interchangeable biosimilar designation carries significant commercial advantages in the U.S. market, as it allows pharmacists to replace the reference product with the biosimilar without requiring approval from the prescribing physician.
Such a designation could help accelerate adoption of AVT16 and improve patient access while creating a larger market opportunity for Alvotech.
The FDA’s decision to accept the application marks a key regulatory milestone as the company continues to expand its biosimilars portfolio and pursue additional growth opportunities in major global healthcare markets.