生成素生物仿制药在美国用于治疗癌症和化疗引起的贫血

Pub Date : 2021-09-15 DOI:10.5639/gabij.2021.1003.015

Charles L. Bennett

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引用次数: 0

摘要

生物仿制药是指在分析特征、药代动力学和药效学、免疫原性、安全性和有效性方面与参比产品高度相似的生物药品。生物仿制药epoetin于2018年获得美国食品和药物管理局(FDA)批准[1]。尽管获得了FDA肿瘤药物咨询委员会(ODAC)的有利审查和2015年FDA对早期配方的非批准函，但该制造商在2017年收到了FDA的非批准函。

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Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

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