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 allowing both manufacturing units at its Reykjavik, Iceland facility to produce the active drug substance for its Humira biosimilar intended for the American market, the company announced Oct. 5, 2026.
The expanded authorization represents a regulatory milestone for the Icelandic biopharmaceutical firm, which had previously faced FDA observations regarding its manufacturing operations. The latest approval signals that agency reviewers are satisfied with the corrective measures Alvotech implemented in response to those earlier findings.
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Alvotech's Humira biosimilar competes in a crowded but lucrative segment of the U.S. biologics market. Humira, AbbVie's blockbuster immunology drug, has faced growing biosimilar competition since the expiration of key patents, making manufacturing capacity and regulatory standing critical competitive factors for rival producers.
By qualifying both production units at the Reykjavik plant under a single supplemental filing, Alvotech gains operational flexibility that could support broader U.S. supply commitments and reduce single-point-of-failure risk in its production chain. The move also reinforces the facility's standing with the FDA after the company's earlier remediation efforts.
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