FDA Expands Alvotech's Humira Biosimilar Production in Iceland
U.S. regulators have approved expanded manufacturing capacity for Alvotech's Humira biosimilar at its Reykjavik plant.
The U.S. Food and Drug Administration has approved a supplement to Alvotech's existing U.S. market authorization for its biosimilar to the blockbuster biologic drug Humira, the Reykjavik-based company announced Monday. The regulatory action allows Alvotech to produce the active pharmaceutical ingredient for the U.S. market across both manufacturing units at its Iceland facility.
The FDA's decision signals the agency's satisfaction with corrective measures Alvotech undertook at the Reykjavik plant following earlier regulatory observations. The supplement approval effectively validates that the manufacturing improvements the company implemented were deemed adequate by federal inspectors.
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Alvotech's Humira biosimilar competes in one of the most closely watched segments of the global pharmaceuticals market. Humira, developed by AbbVie, has historically been among the world's top-selling drugs, making biosimilar competition significant for both payers and patients. Expanded production capacity positions Alvotech to better meet U.S. supply demands from a single, now fully operational dual-unit facility.
The approval represents a meaningful regulatory milestone for Alvotech, reinforcing confidence in its Icelandic manufacturing infrastructure. The company did not disclose a timeline for ramping up production under the expanded authorization.
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