South Korean biopharmaceutical firm Celltrion announced that it filed a request for European Medicines Agency (EMA) approval of CT-P10 on Nov. 10 (local time). CT-P10 is a candidate biosimilar of rituximab, which is used to treat hematological cancer, rheumatoid arthritis and transplant rejection. Accordingly, the company has become the world’s first to submit its proposed rituximab-containing biosimilar.
Since rituximab is an antibody drug that has many medical uses and has relatively shorter substance patent protection, many pharmaceutical companies have been trying to develop a rituxan biosimilar. However, no company has succeeded in the development through clinical trials in developed countries or submitted its approval to regulators in developed countries up to date. In addition, it is so hard to develop a rituximab-containing biosimilar that many international pharmaceutical companies, including Teva Pharmaceutical Industries and Boehringer Ingelheim, have terminated the development.
In 2014, rituximab recorded 9 trillion won (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.
Celltrion is planning to proceed with the licensing procedure in Europe first and the legal confirmation procedure for the validity of collateral patents at the same time.
Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. It was developed by U.S. biotech company IDEC Pharmaceuticals, the current Biogen IDEC, and Swiss drug major Roche is in charge of global sales.