Eye on Pharma: Celltrion's Trastuzumab Biosimilar Gets Canadian Authorization

Republic of Korea—based biosimilar developer Celltrion has announced that its trastuzumab biosimilar, CT-P6, which it markets as Herzuma, has received authorization from Health Canada for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

The biosimilar is also approved in the United States, having earned the FDA’s authorization in 2018 on the basis of a data package that included efficacy, safety, immunogenicity, pharmacodynamic, and pharmacokinetic data from trials conducted in more than 500 patients in 22 countries.

Data supporting the biosimilar’s authorization included those deriving from a phase 3 equivalence trial of CT-P6 as a neoadjuvant treatment in early breast cancer that demonstrated equivalent efficacy of Herzuma to the reference trastuzumab, Herceptin, with a similar proportion of patients achieving pathological complete response with CT-P6 and the reference trastuzumab.

Recently, updated results from a post hoc subgroup analysis from the adjuvant period of treatment demonstrated that the biosimilar, used in the adjuvant setting, has comparable efficacy and safety—including a similar cardiotoxicity profile—to the reference at 1 year.

In the Canadian marketplace, Herzuma will compete both with the reference Herceptin, which is available in intravenous and subcutaneous formulations, and with Mylan and Biocon’s already approved and marketed biosimilar, Ogivri. It is also expected to compete with Pfizer’s Trazimera, which, while approved by regulators, has not yet been marketed in Canada.

Authorization of this latest biosimilar comes as Canada makes concerted efforts to boost biosimilar use in its efforts to provide high-quality treatment at sustainable costs; a Canadian advisory council recently recommended the use of biosimilars in a final report that lays out recommendations for how the country can create a $15.3 billion (approximately US $11.4 billion) universal, single-payer, public system for pharmaceutical coverage.