Omlyclo the first and only omalizumab biosimilar approved in Europe

24 May 2024
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The European Commission (EC) has approved Omlyclo (CT-P39), an omalizumab biosimilar referencing Xolair.

Developed by South Korea’s Celltrion (Kosdaq: 068270), Omlyclo is approved for the treatment of allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP), the company noted.

The EC approval of Omlyclo follows the recommendation for marketing authorization issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March 2024.

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