Celltrion is stepping up as one of the premier biosimilar players, winning approval from the US Food and Drug Administration for the first biosimilar to Genentech/Novartis’ Xolair (omalizumab) blockbuster, including a designation for interchangeability with the reference product.
The Korean firm’s Omlyclo (omalizumab-igec) has been approved for the treatment of moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E (IgE)-mediated food allergy, and chronic spontaneous...
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