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Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: omalizumab

2022

Merck to discontinue Ph III trials of Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer

March 15, 2022

Merck announced that it will discontinue Ph III trials of Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer following the recommendation of an independent Data Monitoring Committee.  Merck said that interim analysis indicated that the combination treatment did not demonstrate a benefit in overall survival.

Celltrion presents new data on CT-39 (biosimilar omalizumab)

March 15, 2022

The Centre for Biosimilars reported on a study on Celltrion’s CT-39 (biosimilar omalizumab) presented at the American Academy of Allergy Asthma and Immunology annual meeting.  Celltrion reported that the study demonstrated equivalence with Xolair® (omalizumab).

RU | Selexis and Generium launch Genolar® (biosimilar omalizumab) in Russia

February 9, 2022

Selexis SA and Generium JSC announced the launch of Genolar® (biosimilar omalizumab) in Russia.

Alvotech and BiosanaPharma announce deal for biosimilar omalizumab candidate

February 2, 2022

Alvotech announced that it has entered into an exclusive global licensing agreement with BiosanaPharma for the co-development of AVT23(BP001), a biosimilar omalizumab candidate.

2021

Celltrion provides update on biosimilars pipeline

November 10, 2021

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

Celltrion reports Q1 2021 financial results

May 12, 2021

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.

2020

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®.

2019

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.

AU | 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.

2018

US | 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®.

2017

US | Clinical trials of omalizumab approved

April 25, 2017

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

2016

CN | 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.

BioBlast® extract From May 16, 2016 to March 15, 2022