Alvotech stock surges after FDA manufacturing approval

Alvotech stock experienced a significant surge on Monday following the U.S. Food and Drug Administration's approval of a supplement to the Biologics License Application for AVT02. The approval enables the company to manufacture the drug substance AVT02, marketed as SIMLANDI in the U.S., in a second production suite at its Reykjavik facility.

The addition of the second suite, DSM2, effectively doubles the drug substance manufacturing capacity available for U.S. supply and provides greater flexibility for commercial operations. Lisa Graver, Alvotech's Chief Executive Officer, emphasized the operational importance of this approval, stating that it represents a regulatory milestone for the Reykjavik facility.

The facility is already approved for manufacturing drug substances for European markets, including AVT02, AVT03, and AVT05. Alvotech anticipates the FDA will consider other pending applications associated with the facility, including BLAs for AVT05, AVT06, AVT03, AVT16/AVT80, and proposed biosimilars to Simponi, Eylea, Prolia, and Entyvio.

AVT02 is already approved as a biosimilar to Humira in over 50 countries. Teva Pharmaceuticals serves as Alvotech's strategic partner for the exclusive commercialization of SIMLANDI in the United States.