Amgen Has Top-Line Phase 3 Results From Biosimilar Candidate To Infliximab

Amgen(NASDAQ:AMGN) today announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with REMICADE^® (infliximab) in patients with moderate-to-severe rheumatoid arthritis. The results confirm non-inferiority compared to infliximab but could not rule out superiority based on its primary efficacy endpoint, which compared the response difference measured by 20 percent or greater improvement defined by the American College of Rheumatology (ACR) Criteria, ACR20, at week 22. Key secondary endpoints included ACR50, ACR70 and Disease Activity Score 28-joint count C reactive protein (DAS28-CRP).

The primary endpoint of ACR20 had a prespecified equivalence margin of +/- 15 percent, and the observed upper end of the confidence interval was 15.96 percent. ACR50 and ACR70 trended in the same direction as ACR20. Notably, the DAS28-CRP difference in mean change from baseline was close to zero (-0.01 [-0.20, 0.17]). Overall, the safety profile and immunogenicity were comparable between ABP 710 and infliximab.

“We believe this study confirms no clinically meaningful differences between ABP 710 and infliximab,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Biosimilars are approved based on the analytical, nonclinical and clinical data, and we believe that the totality of the evidence we’ve generated supports ABP 710 as highly similar to the reference product.”

ABP 710 is being developed as a biosimilar to infliximab, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, which is approved in many regions for the treatment of moderate-to-severe rheumatoid arthritis, chronic severe plaque psoriasis, moderate-to-severe Crohn’s disease, moderate-to-severe ulcerative colitis, psoriatic arthritis and ankylosing spondylitis.

Amgen has a total of 10 biosimilars in its portfolio, including two that are approved in the United States (U.S.) and three that are approved in the European Union (EU).

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