Celltrion announced today that it has obtained marketing approval for Vegzelma (CT-P16), an Avastin biosimilar, from the UK Medicines and Healthcare products Regulatory Agency (MHRA) on September 16 local time.
Celltrion received the marketing approval of Begzelma for the full label approved for Avastin, including metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and metastatic breast cancer.
Following the acquisition of a marketing license from the European Commission (EC) on August 18, the company obtained additional licenses from MHRA and completed the acquisition of marketing licenses in major European markets.
Celltrion Healthcare plans to launch Vegzelma in major European countries in the second half of this year. Celltrion has already completed a global patent agreement with Genentech, the developer of Avastin, and has laid the foundation for stable product release after approval.
At the end of last year, Celltrion has applied for a marketing authorization for Vegzelma to the the Ministry of Food and Drug Safety of Korea and the U.S. The Food and Drug Administration (FDA) and is expected to obtain permission within the year.
According to IQVIA, a global pharmaceutical market research institute, the global bevacizumab market size in 2021 is $6.413 billion (about 8.8 trillion won). Among them, the European and American markets account for $1.614 billion (about KRW 2.215 trillion) and $2.62 billion (about KRW 3.57 trillion), respectively.
