FDA approves first interchangeable biosimilar to Xolair

8 March 2025

On Friday, the US Food and Drug Administration (FDA) approved as the first interchangeable biosimilar to Swiss pharma giant Roche's (ROG: SIX) anti-IgE monoclonal antibody Xolair (omalizumab).

The FDA granted the approval South Korea’s Celltrion (Kosdaq: 068270), which markets its biosimilar under the trade name Omlyclo.

Friday's US nod completes a global regulatory trifecta, following Omlyclo's authorization in the European Union in May 2024 and approval in Canada late last year.

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