April 25, 2024

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[THE INVESTOR] South Korea’s Celltrion filed for regulatory approval for its biosimilar monoclonal antibody of Roche’s blockbuster Herceptin in Europe, the drug maker said on Oct. 31. 

Celltrion submitted CT-P6 -- the proposed biosimilar to breast cancer treatment Herceptin --- to the European Medicines Agency for review after multiple clinical trials in which the primary endpoints have been achieved. 

The global sales of Herceptin, developed by Swiss pharma giant Roche, reached US$6.8 billion last year. 

In 2014, CT-P6 was approved by South Korea’s Ministry of Food and Drug Safety for use on patients with early breast cancer and metastatic gastric cancer. 

The company plans to seek US Food and Drug Administration’s endorsement in the first half of 2017. 

By Park Han-na (hnpark@heraldcorp.com)