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

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal 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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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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来源期刊

GaBI Journal-Generics and Biosimilars Initiative Journal PHARMACOLOGY & PHARMACY-

CiteScore

1.80

自引率

0.00%

发文量

期刊介绍： The scope of GaBI Journal is broad and of interest and relevance to professionals active in clinical practice, pharmaceutical science and policy. Materials published in GaBI Journal include high quality research reports, literature reviews and case studies, all of which are peer reviewed. Manuscripts on all aspects of generic and biosimilar medicines, covering areas in clinical, fundamental, technical, manufacturing, bi-processing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scientific and evidence-based commentaries, may also be considered. In all cases, the emphasis is on quality, originality and knowledge contribution to those involved in health care. All manuscripts submitted to GaBI Journal are subject to a rigorous peer review process. GaBI Journal plans to be indexed in PubMed within two years, and that indexing will be retrospective. GaBI Journal is published quarterly from 2012. All articles are published in English.