mp.weixin.qq.com· 丁香园 Insight 数据库·· 4 hours agoPickScore64
Bio-Thera's BAT2306 Wins NMPA Approval as China's First Secukinumab Biosimilar
首个国产「司库奇尤单抗」获批上市
In brief
Bio-Thera's BAT2306, a biosimilar of secukinumab, was approved by the NMPA on October 22 as the first secukinumab biosimilar approved in China. The application numbers are CXSS2500023/4. The drug was developed under NMPA, FDA and EMA biosimilar guidelines, and DXY Insight database data show its global commercial footprint has already been laid out.
Why it matters
First secukinumab biosimilar approved in China; readers can compare its timing with the originator's China approval to gauge biosimilar entry speed.
Source: mp.weixin.qq.com · mp.weixin.qq.com