FDA Designates ABRILADA as Interchangable Humira Biosimilar

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Pfizer's ABRILADA (adalimumab-afzb) has been designated as an interchangable biosimilar to Humira (adalimumab) by the US Food and Drug Administration (FDA), according to a press release.¹ This designation makes ABRILADA one of only 2 interchangeable biosimilars to Humira, with the other being Cyltezo.

Interchangeability now applies to all FDA-approved indications for ABRILADA, which includes dermatologic conditions such as psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa. Conditions such as rheumatoid arthritis (RA), juvenile idiopathic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and uveitis are also now encompassed by the drug's interchangeability.

The designation is supported by data recently published in The Lancet Rheumatology,² wherein the phase 3 REFLECTIONS B538-12 study demonstrated similar patient outcomes regardless of ABRILADA or Humira use among patients with RA.

“With this designation, ABRILADA 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 ABRILADA and the reference product,” said Roy Fleischmann, MD, lead study author, in the press release.¹ Fleischmann is also clinical professor of Medicine at the University of Texas Southwestern Medical Center.

Beginning at the end of October, Pfizer said ABRILADA will be available at a list price 5% lower than that of Humira, with a second list price 60% lower than that of Humira anticipated later in the year.

References

1. FDA grants interchangeable designation to Pfizer’s Biosimilar ABRILADA. Pfizer. October 5, 2023. Accessed October 5, 2023. https://www.pfizer.com/news/announcements/fda-grants-interchangeable-designation-pfizers-biosimilar-abriladatm.
2. Fleischmann RM, Saikali W, Lakhanpal S, et al. Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: A phase 3, open-label, randomised, Parallel-group study. Lancet Rheumatol. 2023;5(9). doi:10.1016/s2665-9913(23)00161-3