Pfizer announce positive results for Humira biosimilar
Pfizer has released the successful Phase 3 results to its biosimilar to AbbVie’s blockbuster Humira, meeting its primary endpoint in its REFLECTIONS B538-02 clinical study. The news builds upon the success that Pfizer has already achieved last year in building its biosimilar portfolio.
The trial evaluated the efficacy of its drug, PF-06410293, in a comparative, confirmatory study as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12. The trial delved into the efficacy, safety and immunogenicity of the drug, taken alongside in methotrexate, in patients with moderate to severe rheumatoid arthritis. The results compared positively to Humira’s in the same trial.
“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, 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.”
The two other successful results that Ramachandra mentions are a positive trial for a biosimilar to Johnson & Johnson’s Remicade, back in September 2016, and a further potential biosimilar to Roche’s Herceptin. The three successes begin to justify Ramachandra’s claim that Pfizer is manoeuvring itself to be the leader in growing area of biosimilar. The test will come once Pfizer applies to bring the drugs to market.
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