Medscape March 13, 2025
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 for the same four indications as its reference drug: Allergic asthma, chronic rhinosinusitis with nasal polyps, chronic unexplained hives, and food allergies.
The approval “will help broaden access to this important medicine for patients with allergic and respiratory conditions, as well as for physicians, payers and providers,” said Hetal Patel, vice president of medical affairs at Celltrion USA, which makes the drug, in a press release.
Omlyclo is indicated for patients aged 6 years and older with moderate to severe persistent asthma that does not respond to inhaled corticosteroids. A...
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