Two months after the approval of the first biosimilar to infliximab, another Biologics License Application is now under FDA review.
Samsung Bioepis has announced that the FDA has accepted their Biologics License Application (BLA) for SB2, which the company has developed as a biosimliar to Johnson & Johnson's blockbuster drug infliximab (Remicade). The drug is an antiinflammatory agent, actively used to treat rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondilitis, psoriatic arthritis, and psoriasis.
Infliximab-dyyb is manufactured by Celltrion, Inc, based in the Republic of Korea, for Hospira.
According to a press release,
Today's announcement follows the approval of the first biosimilar to infliximab approved 2 months back in the US: infliximab-dyyb. Marketed by Pfizer, Samsung Bioepis’ BLA for SB2 was based on phase 1 and phase 3 clinical studies that tested the biosimilarity of SB2 to infliximab. In a 54-week phase 3 clinical study, SB2 showed comparable safety and equivalent efficacy to infliximab, as evidenced in ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the infliximab arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.
Samsung Bioepis is developing 13 other biosimilar drug candidates that span a broad range of therapeutic areas.