FDA approves Pfizer's biosimilar, ABRILADA™ (adalimumab-afzb) for multiple inflammatory conditions

PfizerPfizer Inc. (NYSE: PFE) announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),(1) for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.(2) For full details of indications please see the approved label.

"Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions," said Richard Blackburn, Global President, Pfizer Inflammation and Immunology. "Our current portfolio of approved biosimilar products is one of the broadest in the industry and we are proud to offer additional treatment options for patients."

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 evaluated the efficacy, safety and immunogenicity of ABRILADA and found no clinically meaningful differences in efficacy, safety or immunogenicity compared to the reference product, each taken in combination with methotrexate, in patients with moderate to severe rheumatoid arthritis.(3)

Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to drive cost savings for healthcare systems. With more than 10 years of global in-market experience and eight approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment.

Pfizer is working to make ABRILADA available to U.S. patients as soon as feasible based on the terms of our agreement with AbbVie. Our current plans are to launch in 2023. We will provide further updates as the date approaches.

About ABRILADA (adalimumab-afzb)

ABRILADA is a tumor necrosis factor (TNF) blocker and biosimilar to Humira. Adalimumab targets and blocks TNF, which is believed to help reduce inflammation.(4)

Please see full Prescribing Information for ABRILADA (adalimumab-afzb).

Pfizer Inc.: 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 150 years, we have worked to make a difference for all who rely on us.

1. Humira is a registered trademark of AbbVie.
2. ABRILADA™ (adalimumab-afzb) Prescribing Information. New York. NY: Pfizer Inc: 2019. Available at http://labeling.pfizer.com/ShowLabeling.aspx?id=12780. Accessed November 2019.
3. Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y. Available at https://www.ncbi.nlm.nih.gov/pubmed/30111357?dopt=Abstract. Accessed November 2019.
4. Zhao S, Chadwick L, Mysler E, Moots RJ. Review of Biosimilar Trials and Data on Adalimumab in Rheumatoid Arthritis. Curr Rheumatol Rep. 2018;20(10):57. Published 2018 Aug 9. doi:10.1007/s11926-018-0769-6. Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097048/. Accessed November 2019.

Most Popular Now

73,000 Scientists collaborate over new COVID-19 Da…

More than 73,000 users collaborate on new online platform set up by the European Open Science Cloud Initiative, where scientists share COVID-19 data and accelerate our un...

Pfizer and BioNTech announce data from preclinical…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced preliminary preclinical data in mouse and non-human primate models from their BNT162b2 mRNA-based v...

Antiviral used to treat cat coronavirus also works…

Researchers at the University of Alberta are preparing to launch clinical trials of a drug used to cure a deadly disease caused by a coronavirus in cats that they expect ...

Search for COVID-19 drugs boosted by SARS discover…

An extensive search and testing of current drugs and drug-like compounds has revealed compounds previously developed to fight SARS might also work against COVID-19. Us...

Sinovac reports preliminary Phase I/II results of …

Sinovac Biotech Ltd. (NASDAQ: SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced that the inactivated COVID-19 vaccin...

COVID-19 study links strict social distancing to m…

Using public transportation, visiting a place of worship, or otherwise traveling from the home is associated with a significantly higher likelihood of testing positive wi...

CureVac expected to receive up to 252 million euro…

CureVac N.V. (Nasdaq: CVAC), a biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA) in clinical trials...

Phase I clinical trial initiated for monoclonal an…

The first participants have been dosed in a Phase I trial of AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of...

Vitamin D deficiency may raise risk of getting COV…

In a retrospective study of patients tested for COVID-19, researchers at the University of Chicago Medicine found an association between vitamin D deficiency and the like...

Europe's largest initiative launches to accelerate…

CARE (Corona Accelerated R&D in Europe) a new consortium supported by the Innovative Medicines Initiative (IMI) public-private partnership announced its launch to acceler...

Blocking cellular communication stops SARS-CoV-2

In the transmission of signals within the cell which, for example, stimulate cell growth or trigger metabolic processes, phosphate groups play an important biochemical ro...

Improving FDA's COVID-19 vaccine authorization and…

On March 28, the Food and Drug Administration (FDA) exercised its Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of ...