FDA accepts Samsung Bioepis filing for Remicade biosimilar

24 May 2016

South Korea-based Samsung Bioepis revealed today that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab).

Samsung Bioepis, which is a joint venture between Samsung BioLogics and US biotech major Biogen (Nasdaq: BIIB), says its drug is directed at the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Remicade is Johnson & Johnson's rheumatoid arthritis drug with $6.6 billion in sales last year.

SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the USA. If approved, the marketing and distribution of SB2 in the US will be handled by Merck & Co, in accordance with a commercialization agreement signed in 2013.

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