Celltrion said that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Vegzelma, a biosimilar referencing Avastin (ingredient: bevacizumab), to treat various cancers.
The company received full label approval for all of Avastin's indications, including metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, and metastatic breast cancer.
The MHRA approval comes after Celltrion received a marketing license for Vegzelma from the European Commission (EC) on Aug. 18.
The company plans to quickly roll out Vegzelma in the global market by utilizing its cost competitiveness.
Celltrion Healthcare, in charge of sales and marketing of Celltrion products, will launch Vegzelma in major European countries in the second half of this year.
The company had completed a global patent agreement with Genentech, the developer of Avastin, and submitted an application for marketing approval for Vegzelma to the Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA).
Celltrion hopes to obtain approval in Korea and the U.S. this year.
"We plan to introduce Vegzelma, our third anticancer antibody biosimilar after Truxima and Herzuma, in the U.K. market as soon as possible," a company official said. "We will also do our best to obtain permits from countries in major regions."
According to IQVIA, a global pharmaceutical market research institute, the global bevacizumab market size in 2021 was $6.413 billion, with the European and U.S. sales accounting for $1.614 billion and $2.62 billion, respectively.
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