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  • Celltrion¡¯s Xolair biosimilar Omlyclo is approved in the US
  • by Chon, Seung-Hyun | translator Alice Kang | Mar 11, 2025 05:54am
First Xolair biosimilar to be approved in the US¡¦interchangeability recognized
Celltrion announced on the 10th that ¡®Omlyclo,¡¯ its biosimilar version of ¡®Xolair¡¯ has was approved by the US Food and Drug Administration (FDA).

Xolair is an antibody biologic used for allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic spontaneous urticaria (CSU). Xolair posted global sales of approximately KRW 6 trillion and over KRW 3 trillion in the US market alone.

Celltrion applied for Omlyclo¡¯s marketing authorization to the FDA based on the results of a global Phase III trial last year and was approved for all indications the original drug was approved for, including allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU),
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