Home Online Features U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
U.S. FDA approves Celltrion’s OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
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Celltrion  
March 9, 2025

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

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