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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With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.
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