FDA approves Abrilada as second interchangeable adalimumab biosimilar
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The FDA has approved Abrilada as the second interchangeable biosimilar to adalimumab, according to a press release from Pfizer.
The approval signifies that Abrilada (adalimumab-afzb, Pfizer) can be substituted for adalimumab (Humira, Abbvie) at the pharmacy level without the intervention or required notification of the prescribing provider — at least where state law allows.
Abrilada is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis and uveitis.
“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,” Roy Fleischmann, MD, of the University of Texas Southwestern Medical Center, said in the Pfizer press release.
According to the company, the FDA’s decision was informed by data from the phase 3 REFLECTIONS B538-12 study, in which the biosimilar demonstrated “similar outcomes” regarding pharmacokinetics, safety and efficacy among patients who switched “multiple times” between the reference product and Abrilada.
“Abrilada was developed with patients in mind, and having an interchangeable designation is a key step toward potentially increasing their access to this important treatment option,” Angela Hwang, chief commercial officer and president of global biopharmaceuticals business at Pfizer, said in the release. “With 15 years of global in market experience in biosimilars and an industry-leading seven marketed biosimilar products in the United States, Pfizer continues to expand options for patient care by introducing Abrilada.”
Abrilada will be available beginning in late October at two price points, according to Pfizer. First, it will launch at 5% less than the list price of originator adalimumab. Then, before the end of the year, it will be available at a rate 60% lower than the originator list price, according to the release.
Abrilada, which was initially approved in November 2019, is the second interchangeable biosimilar to adalimumab to be approved by the FDA. Cyltezo (adalimumab-adbm, Boehringer Ingelheim) received approval as an interchangeable in July.
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