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
Click here to read full press release/ article | Ref: Businesswire | Image: Pharmaboardroom