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
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.