Xolair®| Omalizumab | Genentech / Novartis

October 7, 2020

08 Oct 2020 | All | Celltrion | Korea Biomedical Review reports Celltrion has received approval for Ph III trials of CT-P39 (proposed omalizumab biosimilar).


14 Jul 2020 | All | Celltrion | In an interview with the Centre for Biosimilars, Celltrion's head of marketing, Byoungseo Choi reports Phase I and III trials of Celltrion's omalizumab candidate are ongoing, and are expected to conclude by 2022.


30 Mar 2020 | All | BiosanaPharma | BiosanaPharma releases the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.


16 Jul 2019 | All | Celltrion | Celltrion announces start of Phase I Clinical trials of omalizumab biosimilar, with Phase III trials expected to begin in the first half of 2020.


22 Feb 2019 | AU | Biosana Pty Ltd | Biosana announces approval for Phase 1 trials of biosimilar omalizumab, with results expected in the fourth quarter of 2019.


26 Jul 2018 | US | Glenmark Pharmaceuticals | Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.


25 Apr 2017 | US | Glenmark Pharmaceuticals | Glenmark announces FDA approval for Phase I clinical trials of omalizumab.


16 May 2016 | CN | Sorrento Therapeutics | Sorrento releases results of Phase II and III clinical trials of biosimilar omalizumab, announcing the candidate STI-004 demonstrated clinical efficacy and safety.




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November 9, 2020

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