INCHEON, South Korea I June 4, 2013 I 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 RemsimaTM in Feb. 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 RemsimaTM in July 2012 from the MFDS. In addition, currently, RemsimaTM has been approved by various countries abroad and sales of RemsimaTM have commenced in these foreign markets.
About Celltrion
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing monoclonal antibody biosimilars and novel biopharmaceuticals. For more information, please visit www.celltrion.com.
SOURCE: Celltrion
Post Views: 440
INCHEON, South Korea I June 4, 2013 I 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 RemsimaTM in Feb. 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 RemsimaTM in July 2012 from the MFDS. In addition, currently, RemsimaTM has been approved by various countries abroad and sales of RemsimaTM have commenced in these foreign markets.
About Celltrion
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing monoclonal antibody biosimilars and novel biopharmaceuticals. For more information, please visit www.celltrion.com.
SOURCE: Celltrion
Post Views: 440
