Samsung Bioepis’ Aybintio (biosimilar, bevacizumab) Receives CHMP’s Positive Opinion to Treat Multiple Cancer Indications

Samsung Bioepis’ Aybintio (biosimilar, bevacizumab) Receives CHMP’s Positive Opinion to Treat Multiple Cancer Indications

Shots:

  • The CHMP has recommended the approval of Aybintio in the EU to treat mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer. The EC will review the CHMP’s positive opinion to grant marketing authorization for the therapy
  • The MAA is based on analytical, PK, clinical data, pharmacology, and toxicology data that demonstrated high bio-similarity with no clinically meaningful differences b/w Aybintio and the reference product, Avastin
  • Aybintio is the Samsung Bioepis’ second oncology biosimilar that receives CHMP’s recommendation for approval. The company has submitted the BLA in Sept’2019 which is currently under the US FDA’s review

Click here to read full press release/ article | Ref: GlobeNewswire | Image: Business wire