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# 25th Approved Biosimilar Goes to Pfizer’s Abrilada
- URL: https://www.fdaweb.com/25th-approved-biosimilar-goes-to-pfizers-abrilada/
- Published: 2019-11-18T12:00:00.000Z
- Updated: 2026-09-14T15:53:24.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145525

FDA has hit a milestone with the approval of Pfizer’s [Abrilada (adalimumab - afzb)](https://www.fda.gov/drugs/biosimilars/biosimilar-product-information?ref=fdaweb.com), a biosimilar to AbbVie’s Humira, which is the 25th biosimilar product approved since 2010 when Congress gave the agency authority to approve biologic product knockoffs. Abrilada is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

An [FDA statement](https://www.fda.gov/news-events/press-announcements/statement-sarah-yim-md-acting-director-office-therapeutic-biologics-and-biosimilars-fdas-center-drug?utm%5Fcampaign=FDA%20approves%20Abrilada%20%28adalimumab-afzb%29%2C%20a%20biosimilar%20to%20Humira%20%28adalimumab%29&utm%5Fmedium=email&utm%5Fsource=Eloqua) says this is the ninth biosimilar approved in 2019\. “To date, 74 programs for 38 different reference products have been enrolled in our [Biosimilar Product Development Program](https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval?ref=fdaweb.com) to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace,” it says.

FDA says it continues to advance its [Biosimilars Action Plan](https://www.fda.gov/media/114574/download?ref=fdaweb.com) to improve the efficiency of the biosimilar and interchangeable product development and approval process. “This includes efforts to develop and implement new biosimilar-specific review templates and progress towards the development and validation of pharmacodynamic biomarkers tailored to biosimilar development,” it says.

Additionally, the agency notes that beginning 3/23/2020 it will transition approved BLAs regulated under the Food, Drug, and Cosmetic Act to be approved BLAs regulated under the Public Health Service Act. This will open up biological products like insulin to biosimilar competition.