生物仿制药物的现状与发展

Present Status and Developing Trends of Biosimilar Products

由于生物制品专利保护到期以及价格、规模等因素为生物仿制药物提供了大量的市场和机会。本文就生物制品的主要生产环节和生物仿制药物的结构、生物活性、安全性以及生产稳定性的现状与发展做了概述。

Expiration of patents covering biopharmaceuticals has provided opportunities for biosimilar products.There have been concerns over the similarity between biosimilar products and originator products and product cost reduction.In this paper,the status and trends of bisimilar product manufacturing and characteristics were discussed.