Celltrion Obtains Japanese Approval for Avastin Biosimilar 'Vegzelma' Sales

Celltrion Vegzelma.

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 27th that it has obtained marketing approval from Japan's Ministry of Health, Labour and Welfare for Vegzelma (CT-P16), a biosimilar of Avastin (active ingredient bevacizumab). The indications include metastatic colorectal cancer, non-small cell lung cancer, and metastatic breast cancer.

Following marketing approvals from the European Commission (EC) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), Celltrion has now secured approval in Japan, officially launching its efforts to target major markets in Europe as well as Asia.

Celltrion plans to quickly establish Vegzelma in the Japanese market by leveraging its cost competitiveness derived from in-house drug development and manufacturing expertise, along with the brand power of Herzuma, a breast and gastric cancer treatment that currently maintains a higher market share than the original drug in Japan.

The Celltrion Group offers biosimilar products such as Remsima and Herzuma in the Japanese market. Notably, Herzuma recorded a 54% market share as of the first quarter of this year, surpassing the original product's share.

According to IQVIA, a global pharmaceutical market research firm, the global bevacizumab market size last year was $6.4353 billion (approximately 8.97 trillion KRW), with the Japanese market accounting for $782.1 million (approximately 1.09 trillion KRW). It is the second largest single market after the United States.

A Celltrion official stated, "By obtaining marketing approval for Vegzelma in Japan, we are continuing to secure approvals in major global countries. Following the continuously growing Herzuma in Japan, we will promptly introduce Vegzelma to the market and do our best to strengthen Celltrion's portfolio of oncology antibody biosimilars."

Meanwhile, Celltrion completed its marketing approval applications for Vegzelma with the Korea Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA) at the end of last year and is awaiting approval.

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