Celltrion Inc. announced yesterday that the company has received approval for its cancer treatment biosimilar mAb Herzuma (trastuzumab) from the Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).
This is the second Korean regulatory approval for a Celltrion- developed biosimilar mAb product. Specifically, the MFDS declared that Herzuma has been approved for the treatment of “early and advanced (metastatic) HER2-positive breast cancer as well as advanced (metastatic) stomach cancer.” Herzuma activates the body’s immune system and suppresses HER2 (Human Epidemal growth factor Receptor 2 protein) signals to target and destroy the tumour.
Herzuma is expected to be in the market within the first half of this year after the completion of administrative procedures including notification to the Ministry of Health and Welfare.
Herzuma’s approval is another major milestone for biosimilar development as this approval marks the first approval of oncology biosimilar mAb with global clinical trial results. Celltrion conducted global clinical trials involving 558 patients starting from August 2009 and lasting until December 2011 in 18 countries and 115 sites.
The original product of Herzuma is trastuzumab which has generated sales of over USD 6.3 billion globally in 2012. The Korean domestic market size is estimated at approximately KRW 80 billion (approximately USD 80 million). To date, there have been no biosimilar mAb for breast cancer that have completed clinical trials in Europe or any other developed nations which confirms Celltrion’s advantageous position in the breast cancer biosimilar mAb market.
Celltrion further added that Herzuma’s approval has secured Celltrion with two biosimilar antibodies in its production line. The market size of the two originator products amounts to approximately USD 15 billion. With this approval, Celltrion has become one of the few global pharmaceutical companies with multiple mAbs in their product line. Celltrion has consolidated its leading position in biosimilar development competition through its consecutive biosimilar mAb approvals. In 2013, Celltrion received EMA approval for Remsima? which is the world’s first biosimilar mAb to receive approval from a regulatory agency in a developed country.
The MFDS approval for Herzuma is good news for cancer patients who previously had limited access to advanced therapeutics, in particular, those hindered by the high cost of such originator HER2 antibody biopharmaceuticals such as Herceptin, which was first launched in 1998. Currently in the United States, treatment with this antibody costs around USD 4,500 per month. The two other HER2-targetinged antibodies, pertuzumab (Perjeta), launched in 2012, and the most recently approved ado-trastuzumab emtansine (Kadcyla), cost around USD 6,000 per month and USD 9,800 per month, respectively, in the United States.
In Korea, the price of the original reference product will automatically drop to 70% of the original price as soon as the first biosimilar product is introduced into the market. Herzuma’s approval not only benefits the patients and their families, but also lessens government healthcare burden from high-priced original biologics.
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