OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®, now commercially available in the U.S.
OMLYCLO ® (omalizumab-igec) is the first and only FDA-approved omalizumab biosimilar approved for all four indications of XOLAIR ® (omalizumab) and designated as interchangeable with XOLAIR; OMLYCLO ® will be available in 75 mg/0.5 mL, 150 mg/mL and...
Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®
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 OMLYCLO®...
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
O MLYCLO ® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference...