U.S. FDA approves Celltrion’s OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
OMLYCLO® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDARegulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with