'Avastin' Biosimilar
Recently Approved in Europe, UK, Japan, and Now the US
Fourth FDA-Approved Biosimilar Following Remsima, Truxima, and Herzuma
[Asia Economy Reporter Lee Chun-hee] Celltrion announced on the 28th that it had obtained sales approval from the U.S. Food and Drug Administration (FDA) on the 27th (local time) for 'Vegzelma (CT-P16)', a biosimilar (biopharmaceutical generic) of Avastin (active ingredient Bevacizumab).
This FDA approval covers the major indications of Avastin, including metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, cervical cancer, epithelial ovarian cancer, fallopian tube cancer (uterine tube cancer), primary peritoneal cancer, and circulating glioblastoma. However, metastatic breast cancer was excluded. With this, Celltrion has achieved the remarkable feat of obtaining its fourth FDA biosimilar approval, following Remsima (Remicade biosimilar), Truxima (MabThera biosimilar), and Herzuma (Herceptin biosimilar).
Recently, 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), and the Japanese Ministry of Health, Labour and Welfare on the 26th, major regulatory agencies have successively granted sales approval for Vegzelma, raising expectations as it has now cleared the FDA hurdle. The Korean Ministry of Food and Drug Safety also received the product approval application at the end of last year and expects approval within this year.
In May, Celltrion completed a global patent agreement with Genentech (a Roche subsidiary), the developer of the original drug Avastin, and is accelerating preparations for the global launch of Vegzelma. Celltrion Healthcare, responsible for the sales and marketing of Celltrion products, has established a direct sales system and will directly sell in the U.S., Europe, and other regions. The plan is to sequentially launch the product starting with major European countries in the second half of this year. It must 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 9.1767 trillion KRW). In particular, the U.S. market is the largest single market in the world, reaching $2.602 billion (approximately 3.7104 trillion KRW). Japan, which recently received approval, is also the second largest single market globally, with a size of $782.1 million (approximately 1.1153 trillion KRW).
A Celltrion official said, “Having obtained approvals in major countries such as Europe, the U.S., and Japan, we have completed preparations to target the global market with Vegzelma,” adding, “We will leverage Vegzelma’s cost competitiveness to quickly establish a foothold in the global market and do our best to ensure that the clinical trials and approvals of other biosimilar products currently under development proceed smoothly.”
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