FDA Approves Interchangeable Designation of Biosimilar Adalimumab-afzb

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Results demonstrated comparable safety, immunogenicity, and pharmacokinetics between adalimumab-afzb and the reference product.

The US Food and Drug Administration (FDA) has approved adalimumab-afzb (Abrilada) as an interchangeable biosimilar to the reference drug (Humira), according to a statement made by Pfizer Inc.1 The citrate-free biosimilar is currently approved to treat psoriatic arthritis (PsA), rheumatoid arthritis (RA), juvenile idiopathic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis, uveitis, and hidradenitis suppurativa.

The decision to approve interchangeability was based on data from the Phase 3 REFLECTIONS B538-12, which evaluated the drug among patients with moderate-to-severe active RA who either switched multiple times between the biosimilar 40 mg/.8 mL and the reference product 40 mg/.4 mL, or remained on a continuous dosage of adalimumab, with both groups receiving concomitant methotrexate. Results demonstrated comparable safety, immunogenicity, and pharmacokinetics.

An interchangeable designation is only granted to biosimilars able to meet additional data requirements to confirm the same clinical results in patients switching between the bio-originator and the biosimilar and those who are treated with the bio-originator alone.

Beginning in late October 2023, the biosimilar will be available at a list price 5% below the adalimumab list price. Later this year, it will be available at a second list price 60% below the adalimumab price.

“With this designation, adalimumab-afzb is now both biosimilar to and interchangeable with Humira, reinforcing confidence among physicians and pharmacists that there is no decrease in effectiveness or increase in safety risk associated with switching between adalimumab-afzb and the reference product,” Roy Fleischmann, MD, Clinical Professor of Medicine, University of Texas Southwestern Medical Center, said in a statement.


FDA grants interchangeable designation to Pfizer’s Biosimilar ABRILADATM. Pfizer. (2023, October 5).