Biologicals ( IF 1.7 ) Pub Date : 2020-03-27 , DOI: 10.1016/j.biologicals.2020.02.005 Hye-Na Kang 1 , Robin Thorpe 2 , Ivana Knezevic 1 ,
The World Health Assembly in 2014 adopted a resolution that mandates both Member States and the WHO Secretariat to facilitate access to biotherapeutic products in a way that ensures their quality, safety and efficacy. The availability of biosimilars is expected to increase access to biotherapeutic products by providing more treatment options triggering competition which would lead to a consistent reduction in the average price of treatment. Since the WHO guidelines for regulatory evaluation of biosimilars were issued in 2009, WHO has provided immense effort towards harmonizing the terminology and the regulatory framework for biosimilars globally. This article describes the progress made and the regulatory landscape changes for biosimilars in 21 countries during the past ten years. Based on the information from regulators and from publicly available data, the following has been identified: 1) WHO guidelines have contributed to setting the regulatory framework for biosimilars in countries and increasing regulatory convergence at global level; 2) terminology used for biosimilars is more consistent than in the past; 3) biosimilars are now approved in all participating countries; and 4) the dominant product class for candidate biosimilars under development is monoclonal antibodies.
中文翻译:
生物仿制药的监管前景:2009年至2019年世卫组织的努力和取得的进展。
2014年世界卫生大会通过了一项决议,授权会员国和世卫组织秘书处以确保其质量,安全性和有效性的方式促进获取生物治疗产品的便利。通过提供更多的治疗选择引发竞争,生物仿制药的可用性有望增加获得生物治疗产品的机会,这将导致治疗平均价格的持续下降。自2009年发布世卫组织生物仿制药监管评估指南以来,世卫组织为协调全球生物仿制药的术语和监管框架做出了巨大努力。本文介绍了过去十年来21个国家/地区中生物仿制药的进展和监管格局的变化。根据来自监管机构的信息和可公开获得的数据,确定了以下内容:1)世卫组织准则有助于在各国建立生物仿制药监管框架并在全球范围内促进监管趋同;2)用于生物仿制药的术语比过去更加一致;3)现在所有参与国都批准了生物仿制药;4)正在开发的候选生物仿制药的主要产品类别是单克隆抗体。