BRIEF—Amgen announces top-line results for infliximab biosimilar candidate

Amgen has released results from a Phase III study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Johnson & Johnson’s 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% 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).

"We believe this study confirms no clinically meaningful differences between ABP 710 and infliximab," said Sean Harper, executive vice president of R&D 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," Dr Harper added.

Amgen has a total of 10 biosimilars in its portfolio, including two that are approved in the USA and three that are approved in the European Union.