BRIEF—Teva's biosimilar Herzuma cleared in Canada

Medicines regulator Health Canada has granted a notice of compliance (NOC)1 for Herzuma (trastuzumab), biosimilar to Roche’s Herceptin (trastuzumab) in Canada for the treatment of adult patients with early breast and metastatic breast cancer, and metastatic gastric cancer (MGC), the Canadian subsidiary of Israeli drugmaker Teva Pharmaceutical Industries – which has rights to the biosimilar in certain territories from Celltrion - announced today..

"Canadians are becoming far more aware of biosimilars than in the past years and we are proud to be part of this new era in Canadian health care," said Christine Poulin, senior vice president and general manager of Teva Canada.

The Health Canada NOC issued for Herzuma is based on a review of a comprehensive data package that included efficacy, safety, quality, immunogenicity, pharmacodynamic and pharmacokinetic data from non-clinical and clinical studies.