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Alvotech announced that the FDA has accepted its Biologics License Application for AVT80, a proposed subcutaneous biosimilar of Merck's Entyvio, expanding its biosimilar development pipeline.
Takeda's application for an expanded label for its drug Entyvio, to include use in children, is currently under review by the FDA.
Alvotech shares jumped after the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for a biosimilar to Entyvio for review. This development marks a significant step for Alvotech in bringing its biosimilar to market.