FDA Clears Second Alvotech Plant for Humira Biosimilar Supply
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 expanded manufacturing capacity for SIMLANDI, Alvotech's biosimilar version of AbbVie's blockbuster immunology drug Humira, the Iceland-based biopharmaceutical company announced. The approval allows the drug's active substance to be produced in either of Alvotech's two drug substance suites located at its Reykjavik campus.
The regulatory clearance marks a supply-chain milestone for Alvotech, which markets SIMLANDI — known by its scientific designation AVT02 — in the United States. By qualifying a second manufacturing suite for commercial production, the company gains operational flexibility and potential redundancy in the event of disruptions at either facility.
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Biosimilars to Humira, one of the world's top-selling prescription medicines used to treat conditions ranging from rheumatoid arthritis to Crohn's disease, have faced a competitive and heavily scrutinized market since the first wave of interchangeable entrants arrived in the U.S. Manufacturing credibility and supply reliability are widely viewed as key differentiators in that environment.
Alvotech's Reykjavik operations now encompass dual-suite capability for AVT02 drug substance, a configuration that could help the company better meet commercial demand and satisfy pharmacy and health-system partners seeking supply assurance. The approval does not alter the drug's existing FDA-cleared formulation or indication status.
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