FDA Accepts Application for Remicade Biosimilar

If approved, the product would be marketed by Merck

The FDA has accepted for review a biologics license application (BLA) for SB2 (Samsung Bioepis Co.), a biosimilar candidate referencing Remicade (infliximab, Janssen), for the treatment of rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

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

The BLA for SB2 was based on data from phase 1 and phase 3 clinical studies that tested the biosimilarity of SB2 to Remicade. In a 54-week, phase 3 trial, SB2 showed comparable safety and equivalent efficacy to Remicade, as evidenced in an ACR20 response rate (i.e., at least a 20% improvement in the number of tender and swollen joints, based on American College of Rheumatology criteria) of 65% in the SB2 arm compared with 69% in the Remicade arm. The corresponding results at 30 weeks were 64% and 66%, respectively. The study involved 584 patients with moderate-to-severe RA despite methotrexate therapy at 73 sites in 11 countries.

The Samsung Bioepis pipeline includes the following biosimilar product candidates covering the therapeutic areas of immunology, oncology, and diabetes:

  • SB2 –– biosimilar candidate referencing Remicade (infliximab, Janssen)
  • SB3 –– biosimilar candidate referencing Herceptin (trastuzumab, Genentech)
  • SB4 –– biosimilar candidate referencing Enbrel (etanercept, Amgen)
  • SB5 –– biosimilar candidate referencing Humira (adalimumab, AbbVie)
  • SB8 –– biosimilar candidate referencing Avastin (bevacizumab, Genentech)
  • SB9 (MK-1293) –– biosimilar candidate referencing Lantus (insulin glargine, Sanofi-Aventis)

Source: Samsung Bioepis; May 24, 2016.