Teva Canada announces Health Canada has granted a notice of compliance (NOC) for HERZUMA® (trastuzumab), biosimilar to HERCEPTIN® (trastuzumab) in Canada for the treatment of adult patients with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and Metastatic Gastric Cancer (MGC).
"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. This Health Canada approval of HERZUMA® and the NOC issued for TRUXIMA™ last April leverage Teva's existing expertise in the oncology market and confirms our commitment to Canadians since Teva's biosimilars will have the potential to reduce costs by providing lower-cost treatment options for patients."
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. The totality of evidence submitted to Health Canada demonstrated that HERZUMA® and HERCEPTIN® are highly similar and there were no clinically meaningful differences in purity, potency and safety between them for the three approved indications.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"The HERZUMA® NOC announcement is part of our commitment to a future in biosimilars. Teva Canada will continue to invest in biosimilar programs that includes informative material and educational activities to empower healthcare professionals to make the best choice of treatment for their patients", said Poulin.
A biosimilar biologic drug, or a biosimilar, is a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale (known as the reference biologic drug). Biosimilars are approved based on a thorough comparison to a reference biologic drug. A biosimilar may enter the market after the expiry of the reference biologic drug's patents and data protection.
HERZUMA® is a monoclonal antibody (mAB) biosimilar to HERCEPTIN® that selectively binds with high affinity to extra cellular domain (ECD) of the human epidermal growth factor receptor 2 (HER2). HER2 protein overexpression is observed in breast cancer and gastric cancer. HERZUMA® is the second HERCEPTIN® biosimilar approved by Health Canada for the treatment of adult patients with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and Metastatic Gastric Cancer (MGC).
HERZUMA® was first approved by the South Korea's Ministry of Food and Drug Safety (MFDS) in January 2014. Since October 2016, TEVA Pharmaceutical Industries Ltd. entered into an exclusive partnership with Celltrion Inc. to commercialize HERZUMA® in the U.S. and Canada. The European Commission granted marketing authorization for HERZUMA® in February 2018 and the drug was approved in all 28 EU member states, Norway, Liechtenstein and Iceland (non-members of the EU). In December 2018, HERZUMA® was approved by the Food and Drug Administration (FDA).
Breast Cancer is a cancer that starts in the cells of the breast. Those cells sometimes change and no longer grow or behave normally, which may lead to non-cancerous (benign) breast conditions such as atypical hyperplasia and cysts. It can also lead to a cancerous (malignant) tumor that can grow into and destroy nearby tissue.
Most often, breast cancer starts in cells that line the ducts, the tubes that carry milk from the glands to the nipple, and is called ductal carcinoma. When the cancer starts in the cells of the lobules, which are the groups of glands that make milk, it is called lobular carcinoma. Breast cancer has different stages that describe or classify a cancer based on how much cancer there is in the body and where it is when first diagnosed.