FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

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FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

March 07, 2025 -- Today, the U.S. Food and Drug Administration approved as the first interchangeable biosimilar to Xolair (omalizumab).

Omlyclo, like Xolair, is approved to treat the following conditions:

  • Moderate to severe persistent asthma in patients greater than 6 years of age whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. Testing is performed to see if you have allergies to year-round allergens.
  • Chronic rhinosinusitis with nasal polyps in patients greater than 18 years of age with inadequate response to nasal corticosteroids when used as add-on maintenance treatment.
  • Food allergy in people 1 year of age and older to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. While taking Omlyclo you should continue to avoid all foods to which you are allergic.
  • Chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment.

    • Omlyclo is not indicated for:

  • acute bronchospasm or status asthmaticus
  • the emergency treatment of allergic reactions, including anaphylaxis
  • other forms of urticaria

    • Omlyclo works by binding to immunoglobulin E (IgE), the antibody type that triggers allergic reactions, and blocks IgE from binding to its receptors. Omlyclo is administered subcutaneously for all indications, but it has different dosing instructions for each indication.

    Side effects from Omlyclo include injection site reactions, fever, headache, dizziness, and arthralgia.

    In addition, Omlyclo has a boxed warning for anaphylaxis, which can be life threatening, based on pre-marketing and post-marketing reports of anaphylaxis that occurred after Omlyclo administration. The reaction can occur after the first dose, or after many doses. It may also occur right after a OMLYCLO injection or days later. Omlyclo should only be started in a health care setting equipped to manage anaphylaxis.

    FDA granted the approval of Omlyclo to Celltrion.

    For more information about biosimilar products, including educational information for health care providers and patients, visit www.fda.gov/biosimilars.Source: FDA

    Posted : 2025-03-08 06:00

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