FDA Clears Second Alvotech Plant to Make Humira Biosimilar Simlandi
The FDA approved expanded U.S. manufacturing capacity for Simlandi, allowing Alvotech to produce the drug at either of its two Reykjavik facilities.
The U.S. Food and Drug Administration has approved additional manufacturing capacity for Simlandi, Alvotech's biosimilar to AbbVie's blockbuster immunology drug Humira, the Reykjavik-based biopharmaceutical company announced. The approval gives Alvotech flexibility to produce the AVT02 drug substance at either of its two drug substance suites located in Iceland's capital.
The regulatory clearance is a logistical milestone for Alvotech, which markets Simlandi in the United States as a lower-cost alternative to Humira, one of the world's best-selling prescription medicines. Having two approved manufacturing suites reduces operational risk and can help ensure a more stable commercial supply for U.S. patients and pharmacy partners.
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Biosimilar manufacturers have faced ongoing pressure to demonstrate supply reliability as payers and pharmacy benefit managers increasingly consider biosimilars in formulary decisions. Dual-site approval is a common strategy in the industry to guard against single-point-of-failure disruptions that could leave patients without access to critical medications.
Alvotech has positioned Simlandi as part of a broader push to increase competition in the adalimumab market following the expiration of key Humira patents. Greater manufacturing redundancy could strengthen the company's ability to fulfill contracts and scale up volume if demand accelerates.
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