Samsung Bioepis announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for SB2, a biosimilar candidate to Remicade (infliximab; Janssen), for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

The BLA submission is supported by data from Phase 1 and Phase 3 clinical trials that evaluated the biosimilarity of SB2 to Remicade. In the 54-week Phase 3 trial, 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy were randomized to receive SB2. SB2 was shown to have equivalent efficacy to Remicade (ACR20 response rate of 65.3% vs. 69.2%, respectively) and comparable safety profile at week 54. This fully supports the 30-week study results of 64.1% vs. 66%, respectively. 

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SB2 is the first Samsung Bioepis biosimilar candidate submitted for regulatory review in the U.S. If approved, the marketing and distribution of SB2 in the U.S. will be handled by Merck.

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