作为治疗骨质疏松症的首个内部开发的生物类似药,Teva向FDA和EMA提交了TVB- 009P. Teva submits first internally developed biosimilar, TVB-009P, for osteoporosis treatment to FDA and EMA.

德华制药工业有限公司宣布,FDA和EMA已接受其生物类似药候选剂TVB- 009P的申请,该药用于治疗绝经后妇女的骨质疏松症. Teva Pharmaceutical Industries Ltd. announced that the FDA and EMA have accepted applications for its biosimilar candidate, TVB-009P, aimed at treating osteoporosis in postmenopausal women. 这是Teva首次向美国林业发展局提交内部开发的生物相似材料。 This marks Teva's first internally developed biosimilar submission to the U.S. FDA. 预计这两个机构将在2025年下半年作出决定。 Both agencies are expected to make decisions by the second half of 2025. TVB-009P尚未收到任何管制批准。 TVB-009P has not yet received any regulatory approval.

October 08, 2024

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