FDA accepts for review supplemental application for Abrilada interchangeability – Pfizer

Pfizer Inc. announced that the FDA has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022.

“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.”

The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with Abrilada and its reference product, Humira, both of which were administered with methotrexate in adult patients with moderate to severe rheumatoid arthritis (RA). The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The company anticipates submitting study results for presentation at an upcoming medical congress.

A biosimilar with an interchangeable designation can be substituted for the reference product by a pharmacist, subject to individual state laws. An interchangeable designation is granted by the FDA to biosimilars that meet regulatory requirements, beyond the standards required to establish biosimilarity, to demonstrate that the product is expected to produce the same clinical result as the reference product in any given patient. To achieve an interchangeable designation, the manufacturer must also 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, compared to a reference product without switching.