FDA Approves Biosimilar for Multiple Inflammatory Conditions

Officials from the FDA have approved adalimumab-afzb (Abrilada, Pfizer) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. It is indicated to serve as a biosimilar to adalimumab (Humira). ¹

The approval was based on the review of a comprehensive data package, as well as results from the REFLECTIONS B538-02 clinical comparative study. ¹

REFLECTIONS B538-02 is a randomized, double blind study where the primary endpoint is an equivalent ACR20 response at Week 12 of study treatment. Patients with moderate to severe rheumatoid arthritis would take PF-06410293 in combination with methotrexate. ²

This clinical trial evaluated the efficacy, safety, and immunogenicity of adalimumab-afzb, with no clinically meaningful differences compared to the reference product. ¹

Adalimumab is indicated to target and block TNF, which is presumed to help reduce inflammation. ¹

Reference

• FDA approves Pfizer’s biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions [news release]. New York, NY; Pfizer: November 18, 2019. https://investors.pfizer.com/investor-news/press-release-details/2019/FDA-Approves-Pfizers-Biosimilar-ABRILADA-adalimumab-afzb-for-Multiple-Inflammatory-Conditions/default.aspx. Accessed November 18, 2019.
• Pfizer announces positive top-line results from the comparative reflections B538-02 study for PF-06410293, a potential biosimilar to Humira 1 (adalimumab). Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/pfizer_announces_positive_top_line_results_from_the_comparative_reflections_b538_02_study_for_pf_06410293_a_potential_biosimilar_to_humira_1_adalimumab. Published January 5, 2017. Accessed November 18, 2019.