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FDA accepts Amgen’s biologics license application for biosimilar to adalimumab

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Amgen recently announced in a press release that the FDA has accepted its biologics license application for ABP 501, Amgen’s biosimilar to adalimumab, for review.

The application was submitted on Nov. 25, 2015 following results from phase 3 comparative studies of patients with rheumatoid arthritis and plaque psoriasis treated with either ABP 501 or AbbVie’s originator adalimumab, Humira.

“If approved, we believe ABP 501 could serve as an important additional approved therapeutic option for patients with chronic inflammatory conditions,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in the release. “We look forward to potentially expanding our robust portfolio of approved products, and further demonstrating our continued commitment to delivering high-quality medicines to patients worldwide.”

The FDA has set a Biosimilar User Fee Act target action date of Sept. 25 for the biosimilar.

Currently, adalimumab is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and plaque psoriasis.

Reference:

www.amgen.com