Amgen has submitted a Biologics License Application (BLA) for ABP 710, a biosimilar to infliximab (Remicade; Janssen). The BLA includes data from a Phase 3 comparative efficacy, safety, and immunogenicity study in patients with moderate-to-severe rheumatoid arthritis (RA). 

Infliximab is a tumor necrosis factor (TNF) blocker approved for the treatment of RA, severe chronic plaque psoriasis, moderate-to-severe Crohn’s disease, moderate-to-severe ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.

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The Phase 3 study of ABP 710 (N=558) evaluated the difference in response measured by 20% improvement in ACR core set measurements (ACR20) at week 22. The full data have not been released yet, but the Company “confirmed no clinically meaningful differences between ABP 710 and infliximab.” In addition to the Phase 3 trial data, the BLA submission includes pharmacology and toxicology data. 

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