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  • Conversation: Biosimilars boosted by FDA's landmark ruling for Boehringer’s Cyltezo

    • October 21, 2021 11:02 AM BST
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      Biosimilars boosted by FDA's landmark ruling for Boehringer’s Cyltezo

      The approval by the US Food and Drug Administration (FDA) of Boehringer Ingelheim's Cyltezo as an interchangeable biosimilar for Humira in certain inflammatory diseases looks set to make an already crowded field even more competitive.
      The key difference with this approval is that an interchangeable biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. This can happen at the pharmacy in US states that permit pharmacy-level substitution.
      “The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said acting FDA Commissioner Janet Woodcock. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”
      The FDA approval covers adult patients with forms of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
      The Humira market is worth more than $15bn annually and, in addition to Boehringer's Cyltezo (adalimumab-adbm), other biosimilars that are set to launch in 2023 include Amgen’s Amjevita (adalimumab-atto), Sandoz’s Hyrimoz (adalimumab-adaz), Pfizer’s Abrilada (adalimumab-afzb) and Samsung’s Hadlima (adalimumab-bwwd).
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