Anticancer drug Vegzelma approved for use by Japanese health regulators

Vegzelma, a Celltrion biosimilar of the anticancer drug Avastin [CELLTRION]

Vegzelma, a Celltrion biosimilar of the anticancer drug Avastin, was approved for use by Japanese health regulators, the Korean company said Tuesday.

The green light came after the product was granted permission from the European Commission last month and from Britain earlier this month.

The drug is an identical copy of bevacizumab, better known as Avastin, the name it is marketed under by Switzerland’s Roche. It is used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma.

The global bevacizumab market was valued at $6.4 billion in 2021, with around $782 million coming from the Japanese market. Japan has the world's second-largest bevacizumab market after the United States.

Celltrion applied for use approvals at Korea's Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA). The results are expected to be released within the year.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they cost less.

BY SARAH CHEA [chea.sarah@joongang.co.kr]