Celltrion Obtains UK Sales Approval for Avastin Biosimilar 'Vegzelma'

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 19th that it has obtained marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Avastin (active ingredient bevacizumab) biosimilar 'Beigzelma (CT-P16)'.

Celltrion received marketing authorization for Beigzelma for all indications approved for Avastin, including metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and metastatic breast cancer. Following the marketing authorization obtained from the European Commission (EC) last month, the additional approval from the MHRA completes the marketing authorization in major European markets.

Celltrion plans to quickly establish Beigzelma in the global market by leveraging cost competitiveness derived from its own drug development and manufacturing expertise. Celltrion Healthcare, responsible for sales and marketing of Celltrion products, plans to launch Beigzelma 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 to launch the product stably after approval. At the end of last year, Celltrion also submitted marketing authorization applications for Beigzelma to the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA), expecting to obtain 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 8.8 trillion KRW), with the European and U.S. markets accounting for $1.614 billion (approximately 2.215 trillion KRW) and $2.602 billion (approximately 3.57 trillion KRW), respectively.

A Celltrion official said, “We will do our best to promptly introduce Beigzelma, the third oncology antibody biosimilar following Truxima and Herzuma, to the market and to proceed smoothly with obtaining approvals in major global regions.”

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