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Celltrion to apply for approval of five new biosimilars by the end of 2023

Jun 13, 2023

The Korea Economic Daily reports that Celltrion announced it intends to apply for regulatory approval of five new biosimilars before the end of 2023. Celltrion intends to offer more than 10 biosimilars by 2025, of which it currently offers six.  Celltrion also confirmed that its biosimilar to Amgen’s Prolia® (denosumab) and Genentech’s Actemra® (tocilizumab) are in phase III clinical trials and it intends to apply for their approval by the end of 2023.

Since April 2023, Celltrion has filed MAAs with the EMA for its biosimilar to Janssen’s Stelara® (ustekinumab) and its biosimilar to Genentech/Novartis’ Xolair® (omalizumab), has submitted a phase III IND plan to the FDA for its biosimilar to Genentech’s Ocrevus® (ocrelizumab), and announced positive phase III trials for its biosimilar to Regeneron’s Eylea® (aflibercept).