Creating China's Biosimilar Drugs Regulatory System: A Calculated Approach

Front Pharmacol. 2022 Feb 2:13:815074. doi: 10.3389/fphar.2022.815074. eCollection 2022.

Jianhong Yang¹, Xiaoyu Zhao¹, Jie Li², Kejian Zhang^{1

3

4}, Zheru Zhang⁵, Shunwen Chang⁶, Daotian Fu⁷, Xinhuan Lyu¹, Xianglin Zhang¹, Ying Shao¹

¹ Research center of Yeehong Business School, Shenyang Pharmaceutical University, Beijing, China.
² Overland Pharma (Shanghai) Limited Company, Shanghai, China.
³ School of Pharmaceuticals, Sun Yat-sen University, Guangzhou, China.
⁴ South China Center for Innovative Pharmaceuticals, Guangdong, China.
⁵ I-Mab, Shanghai, China.
⁶ Skyline Therapeutics, Shanghai, China.
⁷ RemeGen, Ltd., Shandong, China.

No abstract available

Keywords: biosimilar drug; efficacy; law and regulation; safety; supervision.