'Avastin' Biosimilar
Recently Approved in Korea Following Europe, UK, Japan, and USA
Building Third Oncology Biosimilar Portfolio After Truxima and Herzuma
[Asia Economy Reporter Chunhee Lee] Celltrion announced on the 29th that it had obtained product approval from the Korea Ministry of Food and Drug Safety for Avastin (active ingredient Bevacizumab) biosimilar (biopharmaceutical generic) 'Vegzelma (CT-P16)'.
This approval covers the full label of Avastin's indications approved in Korea, including metastatic colorectal cancer, non-small cell lung cancer, and epithelial ovarian cancer. With this, Celltrion has established its third oncology antibody biosimilar portfolio following the blood cancer treatment Truxima (MabThera biosimilar) and breast cancer treatment Herzuma (Herceptin biosimilar).
Recently, good news has been coming one after another, starting with the European Medicines Agency (EMA) in August, followed by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on the 16th (local time), Japan's Ministry of Health, Labour and Welfare on the 26th, the US Food and Drug Administration (FDA) on the 27th (local time), and now domestic approval.
In May, Celltrion completed a global patent agreement with Genentech (a Roche subsidiary), the original developer of Avastin, and is accelerating preparations for the global launch of Vegzelma. Celltrion Healthcare has established a direct sales system and will directly market in the US, Europe, and other regions. The plan is to sequentially launch in major European countries starting in the second half of this year. It will need to overcome competition from Pfizer’s ‘Zirabev’, Amgen’s ‘Mvasi’, and Amneal’s ‘Armsys’.
According to IQVIA, a global pharmaceutical market research firm, the global bevacizumab market size last year was $6.4353 billion (approximately 9.1703 trillion KRW). Among single markets, the US and Japan ranked first and second with $2.602 billion (approximately 3.7079 trillion KRW) and $782.1 million (approximately 1.1145 trillion KRW), respectively.
A Celltrion official said, “Following Europe, the UK, Japan, and the US, we have obtained product approval for Vegzelma domestically, sequentially expanding approvals in major global markets. Through this Vegzelma product approval, we have secured the third oncology antibody biosimilar following Truxima and Herzuma, which were previously launched domestically, thereby building a strong portfolio in the oncology antibody treatment market.”
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