U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
Celltrion today announced the U.S. Food and Drug Administration (FDA) approved OMLYCLO® (omalizumab-igec) as the first and ...
Korea JoongAng Daily on MSN3d
Celltrion asthma drug Omlyclo approved for U.S. release
Celltrion said on Monday that its biosimilar Omlyclo had received market authorization for U.S. release. The drug, referencing Xolair, can treat multiple allergic conditions including moderate to ...
Drug Store News1d
FDA approves Celltrion's Xolair biosimilar
Omlyclo is used for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, ...
MedPage Today on MSN3d
First Omalizumab Biosimilar Approved
The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory ...
Managed Healthcare Executive2d
FDA Approves First Biosimilar of Xolair
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy ...
Pharm Exec3d
FDA Approves Celltrion’s Xolair Biosimilar Omlyclo for Multiple Indications
Omlyclo, a biosimilar to Xolair, is indicated for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergies, and chronic ...
Morningstar4d
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 ...
Contract Pharma3d
FDA Approves Celltrion’s Biosimilar to XOLAIR
The FDA has approved Celltrion’s OMLYCLO (omalizumab-igec) as the first and only biosimilar designated as interchangeable ...
Mena FN4d
U.S. FDA Approves Celltrion's OMLYCLO® (Omalizumab-Igec) As The First And Only Biosimilar With Interchangeability Designation Referencing XOLAIR®
"The interchangeability designation of OMLYCLO reinforces confidence among physicians and patients that there is no decrease in effectiveness or increase in safety risk associated with switching ...