FDA Clears Second Alvotech Plant to Make Humira Biosimilar Simlandi
Alvotech wins FDA approval to produce Simlandi drug substance at a second Reykjavik facility, expanding U.S. commercial supply flexibility.
The U.S. Food and Drug Administration has approved additional domestic manufacturing capacity for Simlandi, Alvotech's biosimilar to AbbVie's blockbuster immunology drug Humira, the Iceland-based biopharmaceutical company announced.
The regulatory clearance allows AVT02 drug substance — the active biological component used in Simlandi — to be produced at either of Alvotech's two drug substance manufacturing suites located at its Reykjavik headquarters. Previously, U.S. commercial supply was constrained to a single suite.
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The expanded approval is significant for supply chain resilience. By gaining the ability to shift production between two qualified facilities, Alvotech reduces the risk of supply disruptions that can arise from single-site dependence — a concern that has drawn increased regulatory and industry scrutiny in recent years.
Simlandi, known generically as adalimumab-ryvk, is a high-concentration, citrate-free formulation designed to compete in the crowded U.S. adalimumab biosimilar market that has grown substantially since Humira's exclusivity began eroding. Humira has historically ranked among the world's top-selling prescription drugs, making biosimilar competition in that space commercially consequential.
The manufacturing expansion reinforces Alvotech's strategy of scaling its Reykjavik-based infrastructure to meet U.S. demand without reliance on contract manufacturers for drug substance production. Continue reading at GlobeNewswire - Industry News on Financial Services.
