Celltrion's Avastin biosimilar wins regulatory nod from Canadian authorities

Celltrion announced Thursday that the company has cleared the regulatory hurdle to sell Vegzelma, a biosimilar referencing Roche's Bevacizumab sold under the brand name Avastin, in the Canadian market.

Vegzelma, or also known as CT-P16, is used to treat a number of types of cancers including metastatic colorectal cancer and non-small cell lung cancer.

According to Celltrion, Canada’s drug regulator Health Canada has authorized the sale of the drug for all indications that Roche's Avastin was approved of. The indications include metastatic colorectal cancer, non-small cell lung cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and glioblastoma.

“(Celltrion) will be able to accelerate its businesses in North America upon receiving regulatory nods from Health Canada, as well as from the US Food and Drug Administration in September last year,” an official from Celltrion said.

According to IQVIA’s analytics, the size of the global bevacizumab market was estimated at $6.16 billion. Of the total, the North American market accounts for 44.3 percent, or $2.77 billion.

“Celltrion expects the company's third oncology biosimilar to successfully penetrate the Canadian market, where the government is introducing biosimilar-friendly policies,” a Celltrion official said.

Celltrion said the company will be able to increase its presence the North American bevacizumab market as more states in Canada are expected to allow biosimilars in the future.

In Canada, the government has been making policy efforts to encourage biosimilar prescriptions. Starting with British Columbia, Canada has introduced biosimilar-friendly policy in eight states, including Ontario, which introduced the relevant policy most recently.

Celltrion Healthcare will be in charge of sales of Vegzelma in Canada.

Meanwhile, Celltrion has obtained sales licenses for Vegzelma in a total of 35 countries, including Korea, Europe, the UK. and Japan.

In Europe, Celltrion received an approval from the European Commission in August last year. The UK's Medicines and Healthcare Products Regulatory Agency approved the biosimilar in the following month.

On Wednesday, Celltrion Healthcare, the company’s overseas marketing unit, said that the company inked a partnership with Hikma Pharmaceuticals to launch Vegzelma in 16 countries in the Middle East and North Africa region, including Jordan and Morocco.