Department of Chemical Engineering, DBT Centre of Excellence for Biopharmaceutical Technology, Indian Institute of Technology, Delhi, India.
Prep Biochem Biotechnol. 2021;51(2):201-206. doi: 10.1080/10826068.2021.1876729. Epub 2021 Feb 2.
Development of biotherapeutic products has experienced steady growth over the past three decades. Expiration of patents on many biotherapeutics such as insulin, human growth hormone, and erythropoietin has opened the door for the development of biosimilars. The high cost of biotherapeutics has limited their accessibility, particularly in developing countries. Biosimilars offer the much- needed affordability and hence improved accessibility. Global agencies such as the World Health Organization are engaged in developing a prequalification program in order to help countries that do not have strong regulatory systems. This article summarizes the prospects of biosimilars in the Latin American market. Legal framework in various countries is also discussed.
生物治疗产品的开发在过去三十年中经历了稳步增长。随着许多生物治疗药物（如胰岛素、人生长激素和促红细胞生成素）的专利到期，生物类似药的开发也随之开启。生物治疗药物的高成本限制了它们的可及性，特别是在发展中国家。生物类似药提供了急需的可负担性，从而提高了可及性。世界卫生组织等全球机构正在参与制定资格预审方案，以帮助那些没有强大监管系统的国家。本文总结了生物类似药在拉丁美洲市场的前景。还讨论了各国的法律框架。
