On December 3, 2025, Celltrion announced that the FDA has approved a new dose of OMLYCLO (omalizumab-igec), the first and only biosimilar designated as interchangeable with Genentech and Novartis’s XOLAIR (omalizumab). The FDA approved a 300 mg/2mL solution of OMLYCLO in a single-dose prefilled syringed for subcutaneous injection. Dr. Juby…
On March 9, 2025, Celltrion announced that the FDA has approved OMLYCLO® (omalizumab-igec), the first and only biosimilar of XOLAIR® (omalizumab). The FDA approved OMLYCLO® with an interchangeability designation based on positive phase III data demonstrating comparable efficacy and safety profile with XOLAIR® (omalizumab), which is co-promoted by Genentech and…
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars. According to Sandoz, these…