Biosimilars – status in July 2020 in 16 countries

IF 0.3 Q4 PHARMACOLOGY & PHARMACY

GaBI Journal-Generics and Biosimilars Initiative Journal Pub Date : 2021-03-15 DOI:10.5639/gabij.2021.1001.002

Hye-Na Kang, R. Thorpe, I. Knezevic, Daehyun Baek, Parichard Chirachanakul, H. M. Chua, D. Dalili, F. Foo, K. Gao, Suna Habahbeh, Hugo Hamel, E. Nkansah, M. Savkina, O. Semeniuk, Shraddha Srivastava, João Tavares Neto, M. Wadhwa, Teruhide Yamaguchi

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引用次数: 3

Abstract

The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars are important for health care, as they allow the marketing of safe, efficacious and affordable biological products. Since the first biosimilars were approved in the EU in 2006, a series of biosimilars have been approved in many countries/geographical regions. This manuscript provides the figures on the status of approved biosimilars in 16 countries based on the information from regulatory experts and from publicly available data. It is clear that increasing numbers of biosimilars are now available in many countries and provide more options for treatments. It is expected that adoption of biosimilars will allow affordable health care and greater patient access to important medicinal products. It will also contribute to the overall WHO goal recognized by the World Health Assembly in 2014 by adopting a resolution on access to biotherapeutic products including biosimilars and on ensuring their quality, safety and efficacy.

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生物仿制药- 2020年7月在16个国家获得批准

世界卫生组织为生物类似药产品提供了具体指导，以协助监管机构、制造商和参与开发和评价这些产品的其他专业人员。生物仿制药的开发和批准对卫生保健很重要，因为它们允许销售安全、有效和负担得起的生物产品。自2006年第一批生物仿制药在欧盟获得批准以来，一系列生物仿制药已在许多国家/地区获得批准。本文根据监管专家的信息和公开数据，提供了16个国家批准的生物仿制药状况的数据。很明显，现在许多国家有越来越多的生物仿制药可供使用，并为治疗提供了更多的选择。预计采用生物仿制药将使人们能够负担得起医疗保健费用，并使更多的患者能够获得重要的医药产品。它还将通过一项关于获取包括生物仿制药在内的生物治疗产品以及确保其质量、安全性和有效性的决议，从而促进2014年世界卫生大会确认的世卫组织总体目标。

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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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.