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.
Roche Maintains ‘No Xolair Biosimilars In 2025’ As Celltrion Wins First US Omalizumab Approval
Frontrunner Celltrion Already Holds Approval In Europe, Australia, Korea
While Celltrion has scooped approval for the first biosimilar to Genentech/Novartis’ Xolair in the US – where the reference product achieved sales close to $3bn last year – Genentech’s parent Roche has stated consistently that it is not expecting to face biosimilar competition in 2025.
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