Samsung Bioepis’ Aybintio (SB8, biosimilar, bevacizumab) Receives the EC’s Approval for Launch in EU

Shots:

• The EMA’s CHMP positive opinion was provided in June and is the fifth product which received the EU approval for autoimmune diseases and tumor diseases
• The P-III study results of Abincio which involves 763 patients non-small cell lung cancer (NSCLC) patients and demonstrated the risk ratio of ORR vs original product, also presented at ESMO 2019
•  Aybintio is a mAb targeted for metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer. In Nov 20019, the approval review of BLA is submitted to the US FDA and is also accepted

Click here to read full press release/ article | Ref: Samsung Bioepsis | Image: Twitter