FDA Clears Second Alvotech Plant for Humira Biosimilar Production
Alvotech wins FDA approval to expand U.S. manufacturing capacity for SIMLANDI, its biosimilar to AbbVie's Humira, across two Reykjavik facilities.
The U.S. Food and Drug Administration has approved additional domestic manufacturing capacity for SIMLANDI, Alvotech's biosimilar version of AbbVie's blockbuster immunology drug Humira, the company announced. The regulatory green light allows the drug's active ingredient — known as AVT02 drug substance — to be produced at either of Alvotech's two drug substance suites located in Reykjavik, Iceland.
The expansion gives Alvotech greater operational flexibility and redundancy in its supply chain, reducing the risk of shortages that can affect patients dependent on adalimumab-based therapies. By qualifying a second manufacturing suite, the company can distribute production load and maintain continuity of commercial supply for the U.S. market even if one facility encounters disruptions.
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SIMILANDI competes in a crowded biosimilar adalimumab market that has grown significantly since Humira's U.S. patent protections began expiring. Biosimilars to Humira represent one of the most closely watched segments of the pharmaceutical industry, given that Humira was the world's top-selling drug for years, generating tens of billions of dollars annually for AbbVie.
The FDA approval of expanded capacity signals continued regulatory confidence in Alvotech's Reykjavik manufacturing infrastructure. For payers, pharmacy benefit managers, and health systems seeking lower-cost alternatives to Humira, a more resilient supply chain could support broader adoption of the biosimilar.
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