FDA Expands Alvotech's Humira Biosimilar Manufacturing Approval
The FDA has approved both production units at Alvotech's Reykjavik plant to manufacture its Humira biosimilar for the US market.
The U.S. Food and Drug Administration has granted Alvotech a supplemental approval expanding its authorization to manufacture the active drug substance for its Humira biosimilar at both production units of the company's Reykjavik, Iceland facility, the company announced Monday.
The regulatory action allows Alvotech to scale domestic production of the biosimilar — a near-identical copy of AbbVie's blockbuster immunology drug adalimumab, sold as Humira — across its full Icelandic manufacturing footprint rather than a single unit. The expanded clearance removes a key operational constraint and could improve the company's capacity to supply the competitive U.S. biosimilar market.
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The approval also serves as a formal regulatory signal that the FDA is satisfied with remediation steps Alvotech undertook at the Reykjavik site in response to prior agency observations. Biosimilar manufacturers face rigorous facility inspections, and a clean supplemental approval indicates the plant meets current good manufacturing practice standards across both units.
Alvotech's Humira biosimilar competes in a crowded U.S. market that opened to adalimumab biosimilars in 2023, with multiple products vying for formulary placement among pharmacy benefit managers and health plans. Expanded manufacturing capacity may strengthen the company's ability to fulfill supply agreements with U.S. distribution partners.
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