截至 2025 年 11 月 3 日,Alvotech 公司的生物类似Humira,AVT05 仍在 FDA 审查中,没有新的批准更新.
Alvotech's biosimilar to Humira, AVT05, is still under FDA review as of November 3, 2025, with no new updates on approval.
Alvotech公司宣布,其美国生物许可证申请AVT05(与Humira相似)仍在接受林业发展局的审查,截至2025年11月3日,没有关于批准时间表的新更新。
Alvotech announced that its U.S. Biologics License Application for AVT05, a biosimilar to Humira, remains under review by the FDA, with no new updates on the timeline for approval as of November 3, 2025.
该公司继续与监管当局合作,但尚未收到任何索取补充数据的请求或可能的核准决定。
The company continues to cooperate with regulatory authorities but has not received any requests for additional data or a potential approval decision.