Pfizer nabs FDA approval for Humira biosim

Nov 19, 2019

Pfizer have received approval from the U.S. Food and Drug Administration for Abrilada (adalimumab-afzb), 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.

Pfizer is working to make the drug available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. Abrilada is the fifth Humira biosimilar approved in the U.S. and will join generics from Mylan, Samsung Bioepis and Sandoz when AbbVie's blockbuster has its patent expire in 2023.

Abilada is a tumor necrosis factor (TNF) blocker and biosimilar to Humira. Adalimumab targets and blocks TNF, which is believed to help reduce inflammation.

Read the full Pfizer release