FDA Accepts Supplemental Application for Adalimumab-afzb Interchangeability

The FDA has accepted a Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for adalimumab-afzb (Abrilada, Pfizer) as an interchangeable biosimilar to adalimumab (Humira, Pfizer).

“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, in a press release. “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.”

Adalimumab-afzb, a citrate-free biosimilar to adailimumab, received FDA approval in 2019 for the treatment of certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn disease, ulcerative colitis, and plaque psoriasis.

Positive topline data from the REFLECTIONS B528-12 study supported the PAS, which showed multiple changes between treatment with adalimumab-afzb and its reference product, adalimumab. The biosimilar and the reference product were both administered with methotrexate in adult patients with moderate to severe RA. The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the 2 medicines.

According to a Pfizer press release, a biosimilar with an interchangeable designation can be substituted for the reference product by a pharmacist, subject to individual state laws. Further, an interchangeable designation is granted by the FDA to biosimilars that meet regulatory requirements to demonstrate that the product is expected to produce the same clinical result as the reference product in any given patient.

The manufacturer must demonstrate that there is no additional risk or reduced efficacy if a patient switches back and forth between an interchangeable product and a reference product to achieve an interchangeable designation.

REFERENCE

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability. Pfizer. Accessed February 25, 2022. Accessed February 28, 2022. https://www.pfizer.com/news/press-release/press-release-detail/fda-accepts-review-pfizers-supplemental-application