FDA Clears Second Alvotech Plant for Humira Biosimilar Production
Alvotech wins FDA approval to expand U.S. commercial manufacturing of SIMLANDI across two Reykjavik facilities.
The U.S. Food and Drug Administration has approved additional manufacturing capacity for SIMLANDI, Alvotech's biosimilar to AbbVie's Humira, the company announced. The approval allows AVT02 drug substance destined for the U.S. commercial market to be produced in either of Alvotech's two drug substance suites located in Reykjavik, Iceland.
The regulatory clearance represents a meaningful operational milestone for Alvotech, giving the company greater flexibility and redundancy in its supply chain. With two approved suites now available for U.S.-bound production, the manufacturer is better positioned to meet commercial demand and reduce the risk of supply disruptions that can arise from reliance on a single production line.
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SIMLANDI is a high-concentration, citrate-free formulation biosimilar to Humira, one of the world's best-selling drugs used to treat a range of inflammatory conditions including rheumatoid arthritis and Crohn's disease. The biosimilar market for adalimumab — Humira's active ingredient — has grown increasingly competitive in the United States following the expiration of key patents, making manufacturing scale and reliability critical factors for market participants.
The expansion of approved capacity underscores a broader industry trend in which biosimilar developers are investing in manufacturing infrastructure to compete effectively against both the reference product and rival biosimilar entrants. Regulatory approval of additional production sites typically requires manufacturers to demonstrate that quality and consistency standards are met across all approved facilities.
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