Celltrion's 'Vegzelma' Approved in 35 Countries, Including Canada

Celltrion's 'Avastin' biosimilar 'Vegzelma' (Photo by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion announced on the 5th that it obtained sales approval from Health Canada on the 3rd (local time) for 'Vegzelma (CT-P16)', a biosimilar of 'Avastin' (active ingredient Bevacizumab). With this, Vegzelma has received sales approval in a total of 35 countries, including South Korea, the United States, Europe, the United Kingdom, and Japan.

This sales approval covers all indications (Full Label) approved for the original drug Avastin in Canada, including metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma (a type of brain cancer). Following the U.S. Food and Drug Administration (FDA) approval in September last year, obtaining approval in Canada marks the official entry of Vegzelma into the North American market.

According to IQVIA, a global pharmaceutical market research firm, the global Bevacizumab market size in 2021 reached $6.164 billion (approximately 7.8209 trillion KRW). Notably, the North American market, including the U.S. and Canada, accounts for $2.775 billion (approximately 3.520 trillion KRW), representing 44.3% of the total market.

Canada has been implementing biosimilar-friendly policies since 2019. In British Columbia, which has enforced a biosimilar switching policy, new prescriptions for Bevacizumab are required to be biosimilars. Recently, Ontario also announced the implementation of a biosimilar switching policy, and among Canada's 13 provinces, 8 have adopted related policies, actively fostering an environment that encourages biosimilar prescriptions.

A Celltrion official stated, “We hope that Vegzelma, the third oncology antibody biosimilar following Truxima and Herzuma, will quickly establish itself in the Canadian market. We will continue to do our best to supply high-quality biopharmaceuticals at reasonable prices to provide patients with diverse treatment options.”

This content was produced with the assistance of AI translation services.