FDA Clears Second Alvotech Plant for Humira Biosimilar Production
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 additional manufacturing capacity for SIMLANDI, Alvotech's biosimilar version of AbbVie's blockbuster immunology drug Humira, the company announced. The approval allows the AVT02 drug substance destined for U.S. commercial supply to be produced in either of Alvotech's two drug substance suites located in Reykjavik, Iceland.
The regulatory clearance is a supply-chain milestone for Alvotech, giving the company operational flexibility by eliminating dependence on a single production suite. Dual-site approval is a widely sought designation in the biopharmaceutical industry because it reduces the risk of supply disruptions stemming from manufacturing issues, maintenance shutdowns, or capacity constraints at any one facility.
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SIMLANDI, known by its nonproprietary code AVT02, is a high-concentration, citrate-free formulation of adalimumab — the active ingredient in Humira. Humira has historically ranked among the world's top-selling prescription drugs, and the biosimilar market for adalimumab has grown increasingly competitive since the U.S. market opened to interchangeable and biosimilar versions in recent years.
The expanded manufacturing authorization positions Alvotech to better meet U.S. market demand for its adalimumab biosimilar as competition in the segment intensifies. Analysts have noted that reliable manufacturing scale is a key differentiator for biosimilar makers seeking to secure and retain commercial contracts with pharmacy benefit managers, hospital systems, and insurers.
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