On Oct. 5, Pfizer announced that Abrilada (adalimumab-afzb), its biosimilar to Humira (adalimumab), had received an interchangeable designation from the U.S. Food & Drug Administration (FDA).1 This is the second biosimilar to receive interchangeability status. The first was Cyltezo (adalimumab-adbm).
The interchangeable designation for Abrilada applies to all its approved indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. The designation was supported by data from the phase 3 REFLECTIONS B538-12 study, recently published in The Lancet Rheumatology.
A biosimilar “is a biologic that is highly similar to another biologic that is already FDA approved.”2 Because biologics cannot be copied exactly, biosimilars are not identical to the reference biologic. However, “biosimilars must have no clinically meaningful differences from their original biologic. … Biosimilars provide the same treatment benefits and have the same risks as the original biologic.”2
Additionally, “for approval as an interchangeable biosimilar, manufacturers must provide additional data that reflect how the interchangeable biosimilar may be used in the marketplace with patients. To assess the safety of switching, manufacturers generally conduct studies in which patients alternate between the reference product and the interchangeable biosimilar and compare those patients to patients who are just being treated with the reference product. The results must show no decrease in effectiveness or increase in safety risk associated with switching.”3
An interchangeable biosimilar product may be substituted for the original product without consulting the prescriber, much as generic drugs are routinely substituted for brand name drugs. This is commonly called pharmacy-level substitution and is subject to state pharmacy laws.
Eight biosimilars to adalimumab have been approved by the FDA in 2023.
Learn More
In September, the ACR released biosimilar fact sheets and patient education materials.
Keri Losavio is the editor of The Rheumatologist, a position she has held since 2014.
References
- FDA grants interchangeable designation to Pfizer’s biosimilar Abrilada [press release]. Pfizer. 2023 Oct 5.
- Biosimilar and interchangeable biologics: More treatment choices. U.S. Food & Drug Administration. (n.d.; accessed 2023 Oct 5)
- Interchangeable biological products. U.S. Food & Drug Administration. (n.d.; accessed 2023 Oct 5)
