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.

© 2024 MMIT
Angela Maas

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

Related Posts

fda-approved-rubber-stamp-with-fda-and-pills-on-craft-paper
June 8

New FDA Approvals: FDA Approves Chiesi Group and Protalix’s Elfabrio

READ MORE
fda-approved-rubber-stamp-with-fda-and-pills-on-craft-paper
May 11

New FDA Approvals: FDA Expands Patient Population of Takeda’s HyQvia

READ MORE
fda-approved-rubber-stamp-with-fda-and-pills-on-craft-paper
April 13

New FDA Approvals: FDA Approves Acadia’s Daybue for Rett Syndrome

READ MORE

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today