FDA OKs Pfizer’s Biosimilar of AbbVie’s Blockbuster Drug HumiraBy
The US Food and Drug Administration (FDA) has approved Pfizer’s Abrilada (adalimumab-afzb) as a biosimilar to AbbVie’s blockbuster drug, Humira (adalimumab), an anti-inflammatory drug. Abrilada has been approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Humira is AbbVie’s top-selling product with 2018 global sales of $19.94 billion.
In November 2018, Pfizer signed licensing agreements with AbbVie, resolving all global intellectual matters for Pfizer’s proposed adalimumab biosimilar. Under the terms of the agreements, AbbVie granted Pfizer a non-exclusive patent license for the use and sale of Pfizer’s proposed adalimumab biosimilar for many countries around the world. In the United States, the license period will begin on November 20, 2023.
Pfizer is working to make Abrilada available to US patients as soon as feasible based on the terms of its agreement with AbbVie. The company plans to launch Abrilada in 2023.