Department of Pharmacy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research & the Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
Department of Clinical Pharmacy, School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu, China.
Bioengineered. 2022 Jun;13(6):14503-14518. doi: 10.1080/21655979.2022.2090206.
Biosimilars play an important role in reducing the burden on patients and increasing the market competition. Biosimilar monoclonal antibodies are currently one of the hotspots of research and development in China with policies support. With the continuous improvement of policies, the enthusiasm for the research and development of biosimilars has increased year by year. The policy requirements in different periods have different degrees of impact on the patent applications of pharmaceutical companies. This review introduces the biosimilar monoclonal antibodies market status and approval process in China, analyzes the patents in this field, and helps pharmaceutical companies protect their intellectual property rights.
生物类似药在降低患者负担和增加市场竞争方面发挥着重要作用。生物类似单克隆抗体目前是中国政策支持的研发热点之一。随着政策的不断完善，生物类似药的研发热情逐年提高。不同时期的政策要求对制药公司的专利申请产生了不同程度的影响。本文介绍了中国生物类似药单克隆抗体的市场现状和审批流程，分析了该领域的专利情况，为制药公司保护其知识产权提供帮助。
