Celltrion’s oncology drug Vegzelma (CT-P16), a biosimilar referencing best-selling Avastin (bevacizumab), is authorized for marketing in Japan, the Korean company announced on Monday, adding another key location to its target geography.
Vegzelma, like its reference, is indicated for metastatic colorectal cancer, non-small cell lung cancer, and metastatic breast cancer, among others.
The approval in Japan followed marketing authorization by the European Commission in August and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) last week.
Japan is the second largest bevacizumab market with sales of $782 million behind $2.6 billion in the U.S. as of 2021.
Celltrion will seek to launch Vegzelma in Japan as early as possible to establish its strong position in pipelines for oncology and antibody biosimilars.
Celltrion filed for approval of the drug with the Ministry of Food and Drug Safety in Korea and the U.S. Food and Drug Administration (FDA) late last year. The results are expected to be released within this year.
Celltrion shares were up 1.52 percent at 167,000 won ($117.04) on Tuesday morning, while its marketing subsidiary Celltrion Healthcare rose 1.11 percent to 63,800 won and drug developer Celltrion Pharm added 0.99 percent to 61,100 won.
[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]