3SBio, Hengrui withdraw biosimilar applications

3SBio Inc. (HKSE:1530) and Jiangsu Hengrui Medicine Co. Ltd. (Shanghai:600276) each withdrew NDAs for biosimilars from China FDA review, citing review policies instituted last year that require sponsors to self-inspect and validate clinical data in regulatory applications or withdraw them without penalty (see BioCentury Extra, July 29, 2015).

3SBio said the policies prompted its Sunshine Guojian Pharmaceutical Co Ltd. subsidiary to voluntarily withdrew an NDA for Ipterbin, a biosimilar of Herceptin trastuzumab to treat metastatic breast cancer. 3SBio said Sunshine Guojian "intends to re-submit the clinical trial data of Ipterbin to the CFDA as and when appropriate." CFDA accepted the application in 2011. ...