Celltrion Inc. announced that 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). The newly approved format is a 300mg/2mL solution in a single-dose prefilled syringe for subcutaneous injection. In the United States, OMLYCLO will be marketed and distributed exclusively by Celltrion USA, Inc.
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).
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Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.