Celltrion Obtains European Marketing Authorization for Avastin Biosimilar 'Vegzelma'

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 19th that its Avastin (generic name Bevacizumab) biosimilar 'Vegzelma (CT-P16)' has received marketing authorization from the European Commission.

Vegzelma received marketing approval for all indications approved for Avastin, including metastatic colorectal cancer and non-small cell lung cancer, just over two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in June.

With this approval, Celltrion plans to quickly establish Vegzelma in the market by leveraging its cost competitiveness derived from its own drug development and manufacturing expertise. Celltrion has also completed a global patent agreement with the original drug developer. Celltrion Healthcare, responsible for overseas sales, plans to launch Vegzelma in Europe in the second half of this year.

Vegzelma is the third anticancer antibody biosimilar developed by Celltrion, following the blood cancer treatment 'Truxima' and the breast and gastric cancer treatment 'Herzuma.' At the end of last year, Celltrion also applied for marketing authorization for Vegzelma from the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA), expecting approval within this year.

According to IQVIA, a global pharmaceutical market research firm, the global bevacizumab market size last year was $6.413 billion (approximately 8.5 trillion KRW), with the European and U.S. markets accounting for $1.614 billion (approximately 2.14 trillion KRW) and $2.602 billion (approximately 3.45 trillion KRW), respectively.

A Celltrion official said, "With Vegzelma obtaining marketing authorization from the European Commission, Celltrion has secured its third anticancer antibody biosimilar. We will do our best to ensure Vegzelma is established early by leveraging the competitiveness of the Celltrion Group, which is leading the European biosimilar market, and will proceed smoothly with the remaining global approval processes."