BioCentury | May 30, 2016
Clinical News

Biosimilar trastuzumab regulatory update

3SBio’s Sunshine Guojian Pharmaceutical Co Ltd. subsidiary withdrew an NDA from China Food and Drug Administration (CFDA) for Ipterbin, a biosimilar of Herceptin trastuzumab, to treat metastatic breast cancer. 3SBio cited review policies instituted last...
BioCentury | May 20, 2016
Company News

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...
Items per page:
1 - 2 of 2
BioCentury | May 30, 2016
Clinical News

Biosimilar trastuzumab regulatory update

3SBio’s Sunshine Guojian Pharmaceutical Co Ltd. subsidiary withdrew an NDA from China Food and Drug Administration (CFDA) for Ipterbin, a biosimilar of Herceptin trastuzumab, to treat metastatic breast cancer. 3SBio cited review policies instituted last...
BioCentury | May 20, 2016
Company News

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...
Items per page:
1 - 2 of 2