Shots:

• The US FDA has accepted the BLA for review under the 351(k)pathway for its biosimilar candidate- SB8 referencing Avastin (bevacizumab) which was submitted in Sept’2019
• Following the US FDA’s approval- Merck will commercialize Samsung Bioepis’ SB8 in the US
• SB8 is a biosimilar referencing Roche’s Avastin- designed to treat patients with advanced non-squamous non-small cell lung cancer. With the approval- Samsung Bioepis intends to enhance its biosimilar portfolio targeting immunology- oncology- ophthalmology and hematology

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 Ref: Businesswire | Image: Samsung Bioepis