Celltrion Avastin Biosimilar 'CT-P16' Receives European CHMP Recommendation for Marketing Authorization

[Asia Economy Reporter Lee Gwan-joo] Celltrion announced on the 27th that its Avastin (active ingredient bevacizumab) biosimilar 'CT-P16' has received a 'recommendation for marketing authorization' from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).

Celltrion plans to launch the product globally under the brand name 'Vegzelma' once CT-P16 obtains final marketing approval from the European Commission (EC).

In October last year, Celltrion applied for approval from the EMA for CT-P16 covering the full label indications approved for Avastin, including metastatic colorectal cancer and non-small cell lung cancer. Around the same time, it also applied for marketing authorization from the U.S. Food and Drug Administration (FDA) and expects 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 8.33 trillion KRW), with the European and U.S. markets accounting for $1.614 billion (approximately 2.09 trillion KRW) and $2.602 billion (approximately 3.38 trillion KRW), respectively.

Celltrion has already completed a patent agreement with Genentech, the developer of the original drug Avastin, for global market launch. Following this recommendation for marketing authorization, preparations for market entry are expected to accelerate.

A Celltrion official stated, "With this recommendation for CT-P16 marketing authorization, we are on the verge of obtaining European approval and launching our third oncology antibody biosimilar, following Truxima for hematologic cancers and Herzuma for breast cancer. Having established a solid portfolio of oncology antibody biosimilars, we expect to create synergy with existing products through enhanced market competitiveness. We will continue to do our best to supply high-quality biosimilars at reasonable prices to the market."

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