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Is developing biosimilars regulation policy

2013/8/16      view:
  Yesterday, the director of China medicine institute and Chinese academy of engineering sang guowei on the 7th biological industry convention top BBS said that our country is to formulate relevant examination and approval of biosimilars regulation policy.    
  Sang guowei said that 2014, 45 billion ~ 50 billion biological drug patents expire, biosimilars will face a huge market demand, but at the same time the development difficulty is big, can't think of biosimilars standard can lower than innovation in medicine.       
  Sang guowei, stressed that China is referring to the relevant provisions of the European Union and the world health organization, develop biosimilars regulation policy of examination and approval, will be for building innovative and non varieties different principles of regulatory approval.
    According to introducing, at present the European biosimilars have been established regulatory standards, the United States also made more clear biosimilars regulation, mainly emphasized highly similarity and highly controllable, and how to examine and approve.       
  Sang guowei said that in the "twelfth five-year" and "much starker choices-and graver consequences-in" plan, the development of biomedical technology will be more and more important position. In 2014 after five years will focus on support therapeutic vaccine, synthetic biology technology and products, recombinant coagulation for subclasses, and the development of stem cell therapy, etc.
  Institute of medicine economic south, according to a study by 2015 there will be 64 billion dollars of patent medicine expires, is expected to market will be worth more than $2020 in 200, has a 56% compound rate over the next 10 years. Huahai pharmaceutical vice chairman du jun said that since 2016, the global pharmaceutical industry will be gradually into the era of biosimilars, single, diagnostic reagents and genetic resistance of biosimilars spring has come.
  Vast prospects of biosimilars, attracted many international is given priority to with the original medicine traditional large pharmaceutical companies. Domestic enterprises such as huahai pharmaceutical co., the sea is pharmaceutical industry, fosun pharma companies are actively layout and enter the field.
  However, at present, China's drug approval system has no concept of biosimilars, for biosimilars review of new drug application. Biosimilars regulations, therefore, is not yet clear become the shackles of biosimilars domestic research and development of important factors.