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Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®
Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc.
About this update from Celltrion, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"FDA approval of OMLYCLO® (omalizumab-igec) 300 mg/2 mL solution in a single-dose prefilled syringe for subcutaneous injection expands dosing flexibility and supports tailored treatment for individual patients with certain allergic diseases ","length":239,"tagName":"p"}]},{"val":[{"type":"text","content":"OMLYCLO® (omalizumab-igec) is the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab); The FDA previously approved OMLYCLO® 75 mg/0.5 mL and 150 mg/mL in a single-dose prefilled syringe for subcutaneous injection in March 2025","length":256,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":495,"olType":false},{"type":"text","content":"INCHEON, South Korea, Dec. 1, 2025 /PRNewswire/ -- Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO® (omalizumab-igec), the first and only biosimilar designated as interchangeable with XOLAIR® (omalizumab), in a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the U.S., OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc.","length":467,"tagName":"p"},{"type":"image","alt":"Celltrion CI (PRNewsfoto/Celltrion)","displaySize":"","headline":null,"caption":"Celltrion CI (PRNewsfoto/Celltrion)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":400,"url":"https://media.zenfs.com/en/prnewswire.com/29f7024eb6887049478f3166bdb174c0"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/zhv97G9Xy8993_Mur..7KQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTcwNTtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/29f7024eb6887049478f3166bdb174c0","width":400,"height":400}},"href":"https://mma.prnewswire.com/media/2315627/Celltrion_CI_500px_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"In March 2025, the FDA approved OMLYCLO in 75 mg/0.5 mL and 150 mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection 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).[1]","length":341,"tagName":"p"},{"type":"text","content":""The approval of the additional 300 mg presentation of OMLYCO undersc...