Celltrion anticancer biosimilar Vegzelma approved by Medicines and Healthcare products Regulatory Agency

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Celltrion anticancer biosimilar Vegzelma approved by Medicines and Healthcare products Regulatory Agency

 
Vegzelma, a Celltrion biosimilar of the anticancer drug Avastin, was approved for sale by Britain's Medicines and Healthcare products Regulatory Agency (MHRA), the company said Monday.
 
The approval came only a month after the European Commission granted approval. 
 
The drug is an identical copy of bevacizumab, better known as Avastin, the name it is marketed under by Switzerland’s Roche. It is used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma.
  

Celltrion said it will release the products in the market in the second half. Distribution will be handled by Celltrion Healthcare, its overseas marketing affiliate.
 
The global bevacizumab market was valued at $6.4 billion in 2021, with around 30 percent coming from European markets.
 
Celltrion applied for use approvals at Korea's Ministry of Food and Drug Safety and the U.S. Food and Drug Administration (FDA). The results are expected to be released within the year.
 
Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they cost less.

BY SARAH CHEA [chea.sarah@joongang.co.kr]
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