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Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea

On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original product for breast cancer and metastatic gastric cancer.

Upon receiving MFDS approval for CT-P6, Celltrion plans to launch its second mAb biosimilar product into the Korean pharmaceutical market. Celltrion previously filed for approval of their first biosimilar product Remsima in February 2012 and received approval in July of the same year.

The original product of CT-P6, which is trastuzumab, has generated sales over USD 6.3 billion globally in 2012. CT-P6 is the first trastuzumab biosimilar to enter the regulatory approval procedure.

Celltrion received approval for its first biosimilar product Remsima (biosimilar version of Remicade-infliximab) in July 2012 from the MFDS. In addition, currently, Remsima has been approved by various countries abroad and sales of Remsima have commenced in these foreign markets.
Source: Celltrion press release