Yahoo Finance

U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®

JERSEY CITY, N.J., March 9, 2025 /PRNewswire/ -- Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO ® (omalizumab-igec) as the first and only biosimilar designated ...
Yahoo Finance

Celltrion announces U.S. FDA approval of 300mg strength of OMLYCLO® (omalizumab-igec), the first and only FDA-approved interchangeable biosimilar to XOLAIR®

INCHEON, South Korea, Dec. 1, 2025 /PRNewswire/ -- Celltrion, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new presentation of OMLYCLO ® (omalizumab-igec), the first ...
Monthly Prescribing Reference

Omalizumab Interchangeable Biosimilar Omlyclo Gets FDA Approval

Findings showed equivalent efficacy in change from baseline in weekly itch severity score between omalizumab-igec 300mg and Xolair 300mg. The Food and Drug Administration (FDA) has approved Omlyclo ® ...
Mena FN

U.S. FDA Approves Celltrion's OMLYCLO® (Omalizumab-Igec) As The First And Only Biosimilar With Interchangeability Designation Referencing XOLAIR®

"We are proud to achieve the approval of the first biosimilar to omalizumab in the U.S., which will help broaden access to this important medicine for patients with allergic and respiratory conditions ...