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# Pfizer sBLA for Interchangeable Humira Biosimilar
- URL: https://www.fdaweb.com/pfizer-sbla-for-interchangeable-humira-biosimilar/
- Published: 2022-02-25T12:00:00.000Z
- Updated: 2026-09-14T17:34:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151244

FDA has accepted for review a Pfizer supplemental BLA for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Abbott’s Humira. An interchangeability designation would allow pharmacists to substitute Humira for Abrilada without approval from physicians. The citrate-free biosimilar received [FDA approval](https://www.pfizer.com/news/press-release/press-release-detail/fda%5Fapproves%5Fpfizer%5Fs%5Fbiosimilar%5Fabrilada%5Fadalimumab%5Fafzb%5Ffor%5Fmultiple%5Finflammatory%5Fconditions?ref=fdaweb.com) in 2019 for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. The user fee review action target date is expected in the fourth quarter.

The submission is based on data from the REFLECTIONS B538-12 study that evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis, according to the company. “The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines,” it says.