The Food and Drug Administration (FDA) has accepted for review a supplemental application for Abrilada™ (adalimumab-afzb) seeking to establish the drug as an interchangeable biosimilar to Humira® (adalimumab). An interchangeable biosimilar refers to a biosimilar product that produces the same clinical outcome as the reference product in any given patient.
The Prior Approval Supplement is supported by data from the REFLECTIONS B538-12 study, which assessed multiple switches between Abrilada and Humira, in addition to methotrexate, in adults with moderate to severe rheumatoid arthritis (RA). Results showed that the study met its primary endpoint demonstrating pharmacokinetic equivalence in patients who switched multiple times between both treatment arms. Study results will be submitted for presentation at an upcoming medical congress.
An interchangeable biosimilar product can be substituted for the reference product without requiring a prescription change. This substitution can occur at the pharmacy similar to how generics are substituted for brand name drugs.
“An interchangeability designation for Abrilada would help to support increased use of biosimilars by pharmacists and potentially lead to further cost savings,” said Mike Gladstone, Global President, Inflammation & Immunology, Pfizer. “Today’s announcement builds on our commitment to broaden access to essential, high-quality and cost-effective treatment options for patients living with certain chronic inflammatory conditions.”
In November 2019, the FDA approved Abrilada, a tumor necrosis factor (TNF) blocker, as a biosimilar to Humira for the treatment of certain patients with RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis and plaque psoriasis.
Abrilada will be supplied as a 40mg/0.8mL solution in single-dose pens, prefilled syringes and vials, as well as a 10mg/0.2mL and 20mg/0.4mL solution in single-dose prefilled syringes. The product is expected to be available in the US as early as July 2023.
The FDA is expected to make a decision on the interchangeable designation by the fourth quarter of 2022.
FDA accepts for review Pfizer’s supplemental application for Abrilada™ (adalimumab-afzb) interchangeability. News release. Pfizer Inc. Accessed February 25, 2022. https://www.pfizer.com/news/press-release/press-release-detail/fda-accepts-review-pfizers-supplemental-application