FDA Approves Pfizer’s Adalimumab Biosimilar ABRILADA

On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah Yim, M.D., announced the approval as one of nine new biosimilar products the FDA “has taken action on in 2019, bringing the overall total of biosimilar approvals to 25.” Dr. Yim also noted that “[t]o date, 74 programs for 38 different reference products have been enrolled in [FDA’s] Biosimilar Development Program to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.”

Pfizer and AbbVie announced last year that they had reached a settlement resolving all global intellectual property matters regarding Pfizer’s proposed adalimumab biosimilar, with a U.S. licensing period set to begin on November 23, 2023.  At least eight other companies have entered into license arrangements with AbbVie for their respective adalimumab biosimilars.

Download PDF