Abstract：
The World Health Assembly resolution on access to biotherapeutics in 2014 urges WHO and Member States to facilitate access to biotherapeutics while ensuring their quality, safety, and efficacy. While efforts to date have contributed to increased availability and better access to biotherapeutics, including biosimilars, huge gaps still remain, with lack of product access identified as a problem in many countries. A thorough review of the WHO guidelines on biosimilars issued in 2009 in view of technical developments, accumulated and emerging scientific evidence as well as experience in biosimilar evaluation since the release of the guidelines provided an opportunity to introduce greater flexibility and to reduce regulatory requirements in biosimilar development where possible. Based on the identification, draft revisions of the WHO guidelines were prepared with input from extensive consultation with various stakeholders and the broader public. The move toward a greater emphasis on quality and functional in vitro assessment enables the reduction of cost and timelines of development and supports streamlined regulatory approval as a first critical step toward product availability. This article includes the key updates that have been incorporated in the revised guidelines but are not restricted to these alone and should be read in conjunction with the guidelines.
摘要：
2014年世界卫生大会关于获得生物治疗药物的决议敦促世卫组织和会员国在确保其质量的同时促进获得生物治疗药物。安全,和功效。虽然迄今为止的努力有助于增加生物治疗的可用性和更好的获取，包括生物仿制药,巨大的差距仍然存在，在许多国家，缺乏产品准入被认为是一个问题。鉴于技术发展，对2009年发布的世卫组织生物仿制药指南进行了彻底审查，自指南发布以来，在生物类似药评估方面积累和新兴的科学证据以及经验提供了一个机会，可以在生物类似药开发中引入更大的灵活性并减少监管要求。根据身份，世卫组织指南的修订草案是在与各利益攸关方和广大公众广泛协商后编写的。更加重视质量和功能体外评估的举措可以降低成本和开发时间表，并支持简化的监管批准，这是迈向产品可用性的第一步。本文包括已纳入修订指南的关键更新，但不仅限于这些更新，应与指南一起阅读。
