Alvotech Wins FDA Approval for New SIMLANDI Manufacturing Process: Drug Substance Output More Than Doubles Per Batch
Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in biosimilar medicines, announced in Reykjavik, Iceland, and London on October 20, 2026, that the U.S. Food and Drug Administration (FDA) has approved a new manufacturing process for SIMLANDI (adalimumab-ryvk), its biosimilar to Humira (adalimumab).
The approval allows Alvotech to introduce Process 2.0 for the manufacture of adalimumab drug substance in its DSM2 manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale. Alvotech said the improvement was achieved through targeted process development, effective process transfer and successful process validation, with demonstrated comparability to the previously approved process, maintaining product quality, safety and efficacy.
Joseph McClellan, Chief Operating Officer of Alvotech, said that more than doubling drug substance output per batch while maintaining product quality is a significant achievement reflecting the expertise of the company's process development and manufacturing teams. The new process allows the company to manufacture the same quantity of drug substance in fewer batches, freeing up capacity to support other products in its portfolio, making better use of existing infrastructure and giving it greater flexibility to respond to growing demand. He added that, together with the recent FDA approval of additional manufacturing capacity, the approval demonstrates the strength of the company's Reykjavik operations and its ability to deliver reliable supply to commercial partners.
Founded by Robert Wessman, Alvotech focuses solely on the development and manufacture of biosimilar medicines. Five of its biosimilars are already approved and marketed in multiple global markets, referencing Humira (adalimumab), Stelara (ustekinumab), Simponi (golimumab), Eylea (aflibercept) and Prolia/Xgeva (denosumab), and its commercial partnership network covers markets including the United States, Europe, Japan and China.
Published by GSM · USA (original Chinese edition)
Photo: 图：生物技术生产设施内的生物反应器（资料图）。RickLawless 摄，CC BY 3.0，经 Wikimedia Commons。Photo: bioreactors inside a biotechnology production facility (file photo), by RickLawless, CC BY 3.0, via Wikimedia Commons.
