www.fdanews.com/articles/193618-pfizers-humira-biosimilar-nabs-fdas-25th-approval
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Pfizer’s Humira Biosimilar Nabs FDA’s 25th Approval
December 2, 2019
The FDA handed out its 25th biosimilar approval to Pfizer’s Humira biosimilar Abrilada (adalimumab-afzb) for treating multiple inflammatory conditions.
Abrilada is the fifth Humira biosimilar approved in the U.S. The tumor necrosis factor (TNF) blocker was approved 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 has given the green light to nine biosimilar products so far this year as it implements its Biosimilars Action Plan designed to improve the efficiency of biosimilar development and approval processes.