The U. S. Food and Drug Administration (FDA) has approved Abrilada (adalimumab-afzb), a biosimilar to Humira, for the treatment of juvenile idiopathic arthritis (JIA) in patients 4 and older and for six other inflammatory disorders in adults.
Pfizer, which developed Abrilada, is working to bring the therapy to patients in the U.S. as soon as possible, and expects the medication to be available in 2023.
Besides JIA, Abrilada has been approved for rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and two forms of inflammatory bowel disease, Crohn’s disease and ulcerative colitis.
Biosimilars are medical products nearly identical to reference therapies but are manufactured by a different company after the original patent expires. Such medications usually have lower costs, depending on the country and insurance plans.
Adalimumab, the active compound of Abrilada and AbbVie‘s Humira, is an antibody that specifically blocks tumor necrosis factor (TNF), which is a small inflammatory protein that has been implicated in JIA and other disorders.
“Biosimilars like Abrilada represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions,” Richard Blackburn, global president of inflammation and immunology at Pfizer, said in a press release.
“Our current portfolio of approved biosimilar products is one of the broadest in the industry, and we are proud to offer additional treatment options for patients,” he added.
Other available TNF inhibitors in the U.S. include Enbrel (etanercept), infliximab (marketed as Remicade, Remsima, and Inflectra), Cimzia (certolizumab), and Simponi (golimumab).
To approve a biosimilar, the FDA requires evidence of similar safety and efficacy to the reference product. This is especially important for biologic therapies, such as antibodies, whose effects are more difficult to replicate than those of artificial chemical compounds.
Dosing and route of administration are also the same between biosimilars and branded products.
Abrilada’s approval was based on several data, including the results of Reflections B538-02 (NCT02480153), a randomized, double-blind Phase 3 clinical trial.
The study enrolled 597 participants with moderate to severe rheumatoid arthritis. Half of the participants received Abrilada and the other half received Humira, both in combination with anti-rheumatic treatment methotrexate.
Results showed no clinically meaningful differences in efficacy, safety, or immunogenicity — the ability of a substance to trigger an immune response — between Humira and Abrilada.