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FDA approves additional manufacturing capacity at Reykjavik facility for SIMLANDI
ALVOWAlvotech
The U.S. Food and Drug Administration approved a supplement to the Biologics License Application for AVT02 (SIMLANDI), enabling drug substance production in a second suite, DSM2, at Alvotech's Reykjavik facility. This approval doubles the manufacturing capacity available to support U.S. commercial supply of the biosimilar to Humira and confirms the resolution of prior inspection-related matters at the site. The company expects this regulatory milestone to facilitate action on other pending applications for its pipeline candidates. Alvotech is a biotechnology company focused on the development and manufacture of biosimilar medicines.