FDA Clears Second Alvotech Plant to Make Humira Biosimilar Simlandi
The FDA approved a second Reykjavik manufacturing suite for Alvotech's Simlandi, expanding U.S. commercial supply capacity for the Humira biosimilar.
The U.S. Food and Drug Administration has approved additional domestic manufacturing capacity for Simlandi, Alvotech's biosimilar referencing AbbVie's blockbuster immunology drug Humira, the Icelandic biopharmaceutical company announced.
The regulatory clearance allows the active drug substance for Simlandi, known internally as AVT02, to be produced in either of Alvotech's two drug substance suites located at its Reykjavik, Iceland headquarters. Previously, U.S. commercial supply was tied to a single manufacturing suite, a constraint that the newly approved capacity is designed to resolve.
Read more FDA Expands Alvotech's Humira Biosimilar Manufacturing Approval →
The expansion represents a meaningful operational development for Alvotech as competition in the adalimumab biosimilar market intensifies. Having two qualified manufacturing suites provides the company with greater production flexibility and potential redundancy, reducing single-point supply risk for U.S. customers and commercial partners.
Simlandi is among a growing field of FDA-approved biosimilars referencing Humira, one of the world's top-selling prescription medicines historically used to treat rheumatoid arthritis, plaque psoriasis, and other inflammatory conditions. Broader manufacturing capacity could support Alvotech's ability to compete on volume and reliability in a crowded market.
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