Positive phase III results for Amgen’s infliximab biosimilar

Biosimilars/Research | Posted 20/07/2018 post-comment0 Post your comment

Biotech giant Amgen announced on 27 June 2018 positive data from a phase III study of their infliximab biosimilar (ABP 710) compared to Remicade (infliximab).


Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF‑α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis.

The randomized, double-blind, phase III study evaluated the efficacy and safety of ABP 710 compared to the originator biological, Johnson & Johnson and Merck’s Remicade (infliximab), in patients with moderate-to-severe rheumatoid arthritis. The trial was started in October 2016 and planned to enrol and randomize 558 adults with rheumatoid arthritis. It was carried out at 74 centres in Australia, Bulgaria, Canada, Chile, Czechia, Germany, Hungary, Poland, Spain and the US. The trial was planned to be completed in August 2018.

The results, according to Amgen, confirm that ABP 710 was non-inferior compared to Remicade, but could not rule out superiority based on the 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).

Sean E Harper, Executive Vice President of Research and Development at Amgen, said that Amgen believes that ‘this study confirms no clinically meaningful differences between ABP 710 and infliximab’. He added that the company believes that the totality of the evidence that has been generated ‘supports ABP 710 as highly similar to the reference product’.

Amgen has 10 biosimilars in its portfolio. These include two that are approved in the US, Amjevita (adalimumab-atto) and Mvasi (bevacizumab-awwb) [1], and three that are approved in the European Union, Amgevita (adalimumab), Mvasi (bevacizumab) and Solymbic (adalimumab) [2].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Amgen, ClinicalTrials.gov

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