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FDA approves Alvotech's new SIMLANDI manufacturing process that more than doubles output per batch
ALVOAlvotech
The U.S. Food and Drug Administration has approved a new manufacturing process for Alvotech’s biosimilar SIMLANDI (adalimumab-ryvk). The approval allows the company to implement Process 2.0 at its DSM2 facility in Reykjavik, Iceland, which more than doubles drug substance output per batch without increasing upstream scale. This enhancement improves manufacturing productivity and frees up capacity to support growing demand across Alvotech’s biosimilars portfolio while maintaining product quality, safety, and efficacy. Alvotech is a biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide.