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.1
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.
About Pfizer Inflammation & Immunology
At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to- day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on immuno- inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients living with immuno-inflammatory diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us.