FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

NEW YORK, February 25, 2022 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (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.

Biosimilars play an important role in the treatment of autoimmune conditions. They have the ability to help increase patient access to essential medicines and provide value to the healthcare system by driving market competition that can lower the cost of care. Pfizer is a leader in this vital healthcare segment with more than 14 years of global in-market experience, the first FDA approved biosimilar for the treatment of certain autoimmune conditions and nine approved biosimilars in the U.S.

About ABRILADA (adalimumab-afzb)

ABRILADA is a citrate-free biosimilar to Humira that received FDA approval in 2019 for the treatment of certain patients with RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis. The FDA approval was based on the review of a comprehensive data package which demonstrated biosimilarity of ABRILADA to the reference product. This includes results from the REFLECTIONS B538-02 clinical comparative study, which found no clinically meaningful differences in efficacy, safety or immunogenicity of ABRILADA compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe RA.

Pfizer currently plans to launch ABRILADA in the U.S. as early as July 2023 in accordance with the terms of its agreement with AbbVie.