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Scientific Name: omalizumab

Celltrion recieves approval for Ph III trials of CT-P39

October 8, 2020

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

Results of Phase I and III trials of omalizumab candidate reported

July 15, 2020

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.

Results of Ph 1 trials of BP001 released

March 30, 2020

BiosanaPharma releases the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.

Celltrion announces the launch of Clinical trials of omalizumab biosimilar

July 15, 2019

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

Phase I trials of biosimilar omalizumab approved

February 21, 2019

Biosana announces approval for Phase 1 trials of biosimilar omalizumab, with results expected in the fourth quarter of 2019.

Phase I results of biosimilar omalizumab released

July 26, 2018

Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.

Clinical trials of omalizumab approved

April 25, 2017

Glenmark announces FDA approval for Phase I clinical trials of omalizumab.

Results of clinical trials of biosimilar omalizumab released

May 16, 2016

Sorrento releases results of Phase II and III clinical trials of biosimilar omalizumab, announcing the candidate STI-004 demonstrated clinical efficacy and safety.