Celltrion has received approval in its home market of South Korea for Herzuma, a biosimilar of Roche’s blockbuster Herceptin.
The country’s Ministry of Food and Drug Safety has given the green light to Herzuma (trastuzumab) for HER2-positive breast cancer as well as advanced stomach cancer. Celltrion says the approval “is another major milestone” as it marks the first thumbs-up for “an oncology biosimilar monoclonal antibody with global clinical trial results”. The company conducted studies involving 558 patients from August 2009 to December 2011 in 18 countries and 115 sites.
Celltrion added that in Korea, the price of Roche’s branded drug “will automatically drop to 70%” of its original cost once Herzuma is introduced into the market sometime in the first half of 2014. In September, Celltrion and partner Hospira received European approval for Remsima for their biosimilar of Johnson & Johnson and Merck & Co’s blockbuster Remicade (infliximab).
Interestingly, Roche is one of the companies reportedly interested in buying Celltrion. Earlier this month, the company noted that its largest shareholder, chairman Seo Jung-Jin was in talks to sell his $1.3 billion stake in the company to a multinational. Other potential buyers are AstraZeneca and Teva Pharmaceutical Industries.
