January 5, 2017
Pfizer Inc. has announced that the confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. This trial is evaluating the safety, efficacy, and immunogenicity of PF-06410293 compared to Humira (adalimumab), each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis. PF-06410293 is being developed as a potential biosimilar to Humira.
Sumant Ramachandra, MD, PhD, MBA, Head of Research and Development, Pfizer Essential Health, said: “Today’s announcement builds on Pfizer’s robust biosimilar pipeline which has now delivered positive top-line data results for three of our proposed biosimilars. As the leading global biosimilars company, we continue to advance our commitment to expand access to high-quality treatment options for patients living with chronic, debilitating conditions, such as those in inflammation. Inflammation remains one of the core research areas for Pfizer, spanning over 60 years and including a number of assets in various stages of development.”
This latest data announcement represents the second proposed inflammation biosimilar of Pfizer and the third proposed biosimilar pipeline molecule to report positive top-line results within the past four months. The Pfizer biosimilars pipeline has eight distinct biosimilar molecules in mid to late stage development, and several others in early stage development.