MedPage Today

First Omalizumab Biosimilar Approved

The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory condition in the U.S., drugmaker Celltrion announced Monday. The ...
Monthly Prescribing Reference

Xolair Approved for Adults With Nasal Polyps

The approval was supported by data from the phase 3 POLYP 1 (N=138) and POLYP 2 (N=127) trials evaluating the efficacy and safety of Xolair in adults with nasal polyps who had an inadequate response ...
WTEN

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 ...
Healio

FDA approves omalizumab biosimilar Omlyclo

Please provide your email address to receive an email when new articles are posted on . Omlyclo is the first interchangeable biosimilar to omalizumab (Xolair; Genentech, Novartis). Omlyclo was ...