Pfizer Inc. announced that the comparative, 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 efficacy, safety, 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.
“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,” said Sumant Ramachandra, MD, PhD, MBA, head of research and development, Pfizer Essential Health. “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 Pfizer’s second proposed inflammation biosimilar and the third proposed biosimilar pipeline molecule to report positive top-line results within the past four months. The Pfizer biosimilars pipeline consists of eight distinct biosimilar molecules in mid to late stage development, and several others in early stage development.
REFLECTIONS B538-02 is a multi-national, randomized, double blind, two-arm, parallel group equivalence study [N=597] designed to evaluate the safety, efficacy, and immunogenicity of PF-06410293 (a potential biosimilar to Humira [adalimumab])versus Humira in combination with methotrexate when administered subcutaneously to treat patients with moderate to severely active rheumatoid arthritis (RA) who have had an inadequate response to methotrexate therapy. The primary endpoint is an equivalent ACR20 response (=20% improvement by ACR criteria) at Week 12 of study treatment.
PF-06410293 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Humira (adalimumab).
Humira is currently approved in the US, EU and other markets for multiple indications including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
PF-06410293 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities and is not yet claimed.