Celltrion said that Health Canada has given the go-ahead for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast and gastric cancer.
|Celltrion's anticancer antibody biosimilar Herzuma|
The Canadian authorities approved the drug after validating the comprehensive data from nonclinical and clinical trials, which demonstrated that the safety and efficacy of Herzuma for treating breast and gastric cancer were comparable to the original drug.
Herzuma's reference biologic is Herceptin developed by Genetech and commercialized by Roche.
The original drug is one of the most purchased biomedicine with an estimated 8.7 trillion won ($7.2 billion) in sales in 2018. It has applications for early and metastatic breast cancer and metastatic gastric cancer.
Celltrion Healthcare, which is in charge of overseas distribution and marketing of Celltrion's biosimilars, plans to consult with Teva, the company's distribution partner for Herzuma in North America, to set a launch date for the drug.
The Canadian approval comes after the company obtained the sales approval for Herzuma from the U.S. Food and Drug Administration in December last year. With the recent approval, the company plans to make a full-fledged effort to enter the North American market.
"With the approval of Herzuma, three of Celltrion's antibody biosimilar products have been approved for sale in both the U.S. and Canada," a company official said. "We will do our best to supply high-quality biopharmaceuticals for North American patients."