Posted by Michael Wonder on 18 Nov 2019
FDA approves Pfizer's biosimilar, Abrilada (adalimumab-afzb) for multiple inflammatory conditions
18 November 2019 - Pfizer today announced the United States FDA has approved Abrilada (adalimumab-afzb), as a biosimilar to Humira (adalimumab), 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.
The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of Abrilada to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which evaluated the efficacy, safety and immunogenicity of Abrilada and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.
