Biosimilar Shows Equivalent Efficacy to Humira for RA

Results of a multi-national, randomized, equivalence study show that the investigational biosimilar PF-06410293 demonstrates equivalent efficacy to the biologic Humira (adalimumab; AbbVie) in patients with severe to moderate rheumatoid arthritis (RA) who had an inadequate response to methotrexate therapy.

Called REFLECTIONS B538-02, the study was undertaken to evaluate the efficacy, safety, and immunogenicity of PF-06410293 compared to the biologic Humira in patients with moderate to severe RA.

The study includes 597 patients, all of whom were at least 18 years of age, had a diagnosis of moderate to severe RA, and had received prior methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Patients were excluded from the study if they had untreated or inadequately treated latent or active tuberculosis, uncontrolled clinically significant diseases in the previous 5 years, a history of infection that required hospitalization or parenteral antimicrobial therapy within 6 months before the study.

Patients were randomized to either PF-06410293 or Humira, and all patients also received subcutaneous methotrexate.

Patients in both treatment arms achieved equivalent efficacy as measured by equivalent American College of Rheumatology 20 (ACR20) response (>20% improvement by ACR criteria) at 12 weeks of treatment (primary endpoint of the study). 

Currently, PF-06410293 is an investigational compound under development as a potential biosimilar to Humira and has not received regulatory approval in any country.

According to the press release, PF-06410293 represents the third proposed molecule in Pfizer’s pipeline to show positive “top-line results.” —Mary Beth Nierengarten