Celltrion files CT-P10, proposed Mabthera biosimilar to EMA

November 12, 2015 7:52 AM

South Korean biopharmaceutical firm Celltrion announced that it filed a request for European Medicines Agency (EMA) approval of CT-P10 on Nov. 10, Business Korea reports.

CT-P10 is a candidate biosimilar of rituximab, widely known as Rituxan (and Mabthera outside US). In 2014, rituximab recorded US$7.78 billion in global sales. Its patents already expired in Europe in December 2013 and will expire in the U.S. in September 2016. Although the patents on rituximab in Korea expired in October 2013, its collateral patents, including five formulation and use patents, are still protected.

Although the application has been made, it is still unclear which indications Celltrion is seeking. There are rumours that, the company has made the application only for Rheumatoid Arthritis indication, which is still a very small portion of the whole rituximab business.

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