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- by manilatimes.net
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U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference product XOLAIR® (omalizumab)[1] The availability of the first omalizumab biosimilar will help increase access and potentially lower the healthcare cost for people with asthma and allergic diseases JERSEY CITY, N.J., March 10, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab) for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), Immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous urticaria (CSU).[2]