Health Canada Approves Samsung Bioepis’ Ontruzant Biosimilar

Incheon, Korea-based Samsung Bioepis received approval for single-use and multi-dose vials of its biosimilar referencing Herceptin (trastuzumab), Ontruzant (SB3), in the Canadian market.

The 150 mg single-dose vial and the 440 mg multi-dose vial of the drug were approved by Health Canada, the nation's regulatory agency, for the treatment of adults with early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

“Breast cancer is both the most common cancer and second leading cause of death from cancer among Canadian women. As a leading biosimilar company, we are very proud to be granted an approval of our Ontruzant bringing an alternative treatment option for patients,” said Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, in a statement.

The approval marks the company’s fifth biosimilar to be authorized for use in Canada, following the approvals of Brenzys (etanercept) in August 2016, Renflexis (infliximab) in December 2017, Hadlima (adalimumab) in May 2018, and Aybintio (bevacizumab) in November 2021. Additionally, Simlandi, a high-concentration citrate-free adalimumab biosimilar developed by Alvotech, was approved in January 2022.

Brenzys references Enbrel, Renflexis references Rituximab, Hadlima and Simlandi are biosimilars for Humira, and Aybintio references Avastin.

Additionally, Ontruzant is the third trastuzumab biosimilar to be approved in Canada, following Mylan and Biocon’s Ogivri (approved in May 2019) and Celltrion Healthcare’s Herzuma (approved in 2019).

Ontruzant will be commercialized in Canada by Organon, a publicly traded spinoff biosimilars company created by Merck. Merck and Samsung Bioepis have been involved in a commercialization partnership since 2013 for multiple biosimilars. After Merck decided to turn its spinoff into a full-fledged company, Organon took over the marketing of biosimilars under that agreement but it does not participate in research and development.

According to Samsung Bioepis, the approval was based on evidence collected during analytical and pharmacokinetic clinical trials that also assessed the pharmacology and toxicology profiles of Ontruzant.

Recent results from a phase 3 study that were presented at the 2021 San Antonio Breast Cancer Symposium confirmed the long-term clinical safety of Ontruzant up to 68 months in patients with human epidermal growth factor receptor 2 (HER2)–positive early or locally advanced breast cancer. Another study presented at the European Society for Medical Oncology (ESMO) Congress 2021 showed positive safety and efficacy findings for the drug over the course of 5 years in a similar population of patients.

“We have strong belief that Ontruzant will contribute in expanding patient access in Canada. Samsung Bioepis will continue our advancement in biosimilar pipelines so that cancer patients and healthcare system[s] in Canada will benefit from biosimilars,” said Jung.

Ontruzant is available in the United States and the European Union. It was granted marketing authorization in Europe in November 2017 and was launched in the United States in April 2020. The drug was also made available to patients with early and metastatic HER2-positive breast cancer or advanced gastric cancer in Brazil in August 2020.

In December 2019, Ontruzant became the first biosimilar to be granted prequalification status by the World Health Organization for use in patients with HER-2 positive cancer in low- and middle-income countries.