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FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications

UnknownApr 15, 2026(27 days ago)

FDA and EMA Accept Teva’s Omalizumab Biosimilar Applications

On March 30, 2026, Teva announced that the FDA and the European Medicines Agency (EMA) accepted regulatory submissions for its proposed biosimilar to Xolair® (omalizumab), TEV-45779.... By: Venable LLP

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