New FDA Approvals: FDA Expands Label of Pfizer’s Abrilada

June 14: The FDA expanded the label of Pfizer Inc.’s Abrilada (adalimumab-afzb) to include the treatment of moderate to severe hidradenitis suppurativa in adults. The agency first approved the biosimilar of AbbVie Inc.’s Humira (adalimumab) on Nov. 15, 2019. Dosing starts with 160 mg via subcutaneous injection on day one or split over two consecutive days, then 80 mg on day 15, and then on day 29 and subsequent doses, 40 mg every week or 80 mg every other week. Drugs.com lists the price of two 40 mg/0.4 mL kits and two 40 mg/0.8 mL kits of Humira, each with two devices, as more than $7,299. Pfizer told AIS Health, a division of MMIT, that it would launch the tumor necrosis factor (TNF) inhibitor in “late third-quarter/early fourth-quarter 2023” per the settlement of patent litigation with AbbVie.

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