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

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  Ref: GlobeNewswire | Image: Samsung Bioepis