Samsung Bioepis Reports FDA’s Acceptance of BLA for SB8 (biosimilar, bevacizumab)

Samsung Bioepis Reports FDA’s Acceptance of BLA for SB8 (biosimilar, bevacizumab)

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