Alvotech获FDA批准SIMLANDI新生产工艺：单批原料药产量翻倍以上
生物技术公司 Alvotech（NASDAQ: ALVO）2026年10月20日在 Reykjavik 与 London 宣布，美国食品药品监督管理局（FDA）已批准其生物类似药 SIMLANDI（adalimumab-ryvk）的新生产工艺。SIMLANDI 是原研药 Humira（adalimumab）的生物类似药。
此次批准允许 Alvotech 在其位于 Iceland 首都 Reykjavik 的 DSM2 生产区采用名为 Process 2.0 的新工艺生产 adalimumab 原料药。在不改变上游生产规模的情况下，新工艺使每批原料药产量提高一倍以上。公司表示，这一改进来自有针对性的工艺开发、有效的工艺转移与成功的工艺验证，新工艺产品与此前获批工艺的可比性已得到证明，产品质量、安全性和有效性保持不变。
Alvotech 首席运营官 Joseph McClellan 表示，在保持产品质量的同时让单批原料药产量翻倍以上，体现了公司工艺开发与生产团队的专业能力；新工艺使公司能用更少的批次生产同样数量的原料药，从而腾出产能支持产品组合中的其他产品，更好地利用现有基础设施，并更灵活地应对增长的需求。他还提到，这一批准与 FDA 近期批准该公司新增生产产能一道，显示了 Reykjavik 运营基地的实力。
Alvotech 由 Robert Wessman 创立，专注于生物类似药的开发与生产，目前已有五款生物类似药在全球多个市场获批上市，参照原研药包括 Humira、Stelara、Simponi、Eylea 与 Prolia/Xgeva，商业合作网络覆盖美国、欧洲、日本、中国等市场。公司称，随着其生物类似药需求持续增长，可靠供应商业伙伴是此次工艺升级的目的之一。
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.
发布：GSM·美国（发布链接）
图片来源：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.
GSM Global · 本篇英文版 English edition of this story
