Abstract：
Biosimilars have played a significant role in alleviating healthcare burdens and enhancing patient access to high-quality biologic-based pharmaceutical therapies. The World Health Organization (WHO), as well as various national governments and regulatory agencies, have established corresponding regulations and guidelines to encourage the development of biosimilars. China, as a populous nation with a substantial demand for biologic therapies, has made substantial investments in the research and development (R&D) of a number of biosimilars, making it the global leader in terms of the number of biosimilar varieties developed and the companies involved. This article summarizes the landscape of biosimilar R&D and registration in China, the development of regulatory science for biosimilars (including guidelines) in China, the challenges faced in biosimilar development in China, and a discussion of and suggestions for tailoring or even waiving comparative clinical efficacy studies.
摘要：
生物仿制药在减轻医疗保健负担和增加患者获得高质量的基于生物的药物治疗方面发挥了重要作用。世界卫生组织（WHO），以及各国政府和监管机构，建立了相应的法规和准则，以鼓励生物仿制药的发展。中国,作为一个对生物疗法有大量需求的人口大国，在许多生物仿制药的研发（R＆D）上进行了大量投资，使其在开发的生物仿制药品种数量和相关公司方面处于全球领先地位。本文综述了我国生物仿制药研发与注册的现状,中国生物仿制药监管科学(包括指南)的发展，中国生物仿制药开发面临的挑战，以及对定制甚至放弃比较临床疗效研究的讨论和建议。
