Center for Biosimilars19h
The Top 5 Biosimilar Articles for the Week of March 10
To read all of these articles and more, visit centerforbiosimilars.com.
Korea JoongAng Daily on MSN5d
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 News2d
FDA approves Celltrion's Xolair biosimilar
Omlyclo is used for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, ...
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 ...
MedPage Today on MSN5d
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 Executive4d
FDA Approves First Biosimilar of Xolair
Celltrion’s Omlyclo is interchangeable with Xolair to treat the same conditions: asthma, chronic rhinosinusitis, food allergy ...
BioWorld3d
Celltrion wins FDA approval of denosumab, omalizumab biosimilars
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along ...
Contract Pharma4d
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 ...
Morningstar5d
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 ...