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Celltrion's corporate logo (Celltrion) |
The Medicines and Healthcare products Regulatory Agency -- the UK’s drug authorization body -- has granted Celltrion sales approval for oncology biosimilar Vegzelma in the country, the South Korean company announced Monday.
According to Celltrion, Vegzelma was authorized for the treatment of multiple types of cancer including metastatic breast cancer, non-small cell lung cancer, ovarian cancer and cervical cancer.
The UK approval came a month after Vegzelma received a green light from the European Commission in August, allowing the anticancer biosimilar product’s market entrance in the region. Vegzelma is Celltion’s third oncology biosimilar product to be approved in Europe.
Celltrion Healthcare, which is in charge of marketing and sales of Celltrion products, plans to release Vegzelma in major European countries in the second half of this year, according to the company.
“Following Truxima and Herzuma, we will do our best to show Vegzelma -- our third anticancer biosimilar -- to the market promptly and obtain approvals from countries in major global regions smoothly,” said a Celltrion official.
Celltrion requested product sales approval of Vegzelma from the South Korean Ministry of Food and Drug Safety as well as the US Food and Drug Administration last year. The company said it is expecting authorization before the end of this year.
As a bevacizumab biosimilar referencing Avastin, an anticancer drug developed by multinational pharmaceutical company Roche, Vegzelma showed similar safety, efficacy and pharmacokinetics in the clinical trial results, according to Celltrion.
