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    Pfizer Abrilada, biosimilar to Humira gets USFDA nod for multiple inflammatory conditions

    Farhat NasimBy Farhat NasimPublished On 2019-11-20T12:44:55+05:30  |  Updated On 2021-08-13T15:07:28+05:30

    New Delhi: Pfizer Inc. recently announced the United States (U.S.) Food and Drug Administration (USFDA) has approved ABRILADA (adalimumab-afzb), as a biosimilar to Humira (adalimumab), 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.


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


    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.


    Also Read: Pfizer cancer drug Ibrance higher sales beat Q3 profit estimates

    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.


    Commenting on the same, Richard Blackburn, Global President, Pfizer Inflammation and Immunology said, "Biosimilars like ABRILADA represent an opportunity to help improve access to important treatment options for patients living with chronic, and often debilitating, inflammatory conditions."


    "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, " Blackburn added.


    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.


    Also Read: Mylan, Pfizer says Mylan-Upjohn combined entity to be known as Viatris
    Abrilada biosimilar Humira multiple inflammatory conditions Pfizer pharma pharma company pharma news US Food and Drug Administration USFDA approved 

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    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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