FDA to review Samsung Bioepis' BLA for Remicade biosimilar

• The FDA accepts for review the Biologics License Application (BLA) from Samsung Bioepis for SB2, its biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). SB2 is the company's first biosimilar to be submitted for review in the U.S.
• If approved, Merck (NYSE:MRK) will be responsible for marketing and distribution.
• Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB). It has 13 biosimilar candidates in its pipeline, including six in its first wave.