MedPage Today on MSN14d
First Omalizumab Biosimilar Approved
The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory ...
Morningstar14d
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 ...
Medscape11d
FDA Approves First Biosimilar to Omalizumab
The US Food and Drug Administration (FDA) has approved the first biosimilar form of omalizumab (Xolair) for the treatment of a range of allergic conditions. Omalizumab-igec (Omlyclo) is designed ...
Drug Store News11d
FDA approves Celltrion's Xolair biosimilar
Omlyclo is used for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, ...
BioWorld6d
Celltrion wins FDA approval of denosumab, omalizumab biosimilars
Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Center for Biosimilars9d
The Top 5 Biosimilar Articles for the Week of March 10
To read all of these articles and more, visit centerforbiosimilars.com.
European Medical Journal10d
Advances in Allergic Asthma Treatment: A Comparative Study
Discover a study that compared the effectiveness of P043 versus omalizumab in managing uncontrolled allergic asthma.
The Manila Times14d
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 FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable ...