The Intelligence Study Of Regulatory Issues On The Biosimilars

In recent years, biosimilars have become a world focusin the field of pharmaceutical and treatmentapplications.Biosimilars are similar to the original reference medicine and have even better effectiveness; purity and safety, besides, biosimilars are much cheaper than theircorrespondingreferenceproducts. Therefore, it is easy to see that biosimilars have bright prospect of clinical application and huge market potential. In order to develop biosimilars, it is necessary to develop a suitable regulation system of biosimilars. Nowadays in the world, The EU has more than ten-year experience of biosimilars’ approval and has already established a nearly complete guideline and regulation system. As a country that has the most advancedbiotechnology, the US approved the first biosimilar product and released the first formal guideline of biosimilars in 2015. Subsequently, Chinese first guideline of biosimilars is released by China Food and Drug Administration(CFDA) in the same year. The study aims to analysis the several nations’ regulatory pathways of biosimilar systematically.The thesis develops the study through three stages including proposing, analysis and solving of issue. On the basis of comprehensive utilization of multiple methods for intelligence analysis, the author comparatively analyzed the developments in the regulatory systems for biosimilars in EU, the US, India and China, and find out what differs and make differences in the process.In the EU,the European Medicines Agency(EMA) created a guideline framework for biosimilars in 2005. The EMA published several Product-specific biosimilar guidelines and other guidelines relevant for biosimilars subsequently. And in 2013, the EMA approved the first biosimilar of monoclonal antibodies—Remsima, which is a milestone for biosimilars.The US is strict with the approve of biosimilars, the Food and Drug Administration(FDA) released draft overarching guidelines in 2014, then in 2015, the FDA released several formal guidelines of biosimilars. And at the same year, the FDA approved the first biosimilar in the US, zarxio, which refers Filgrastim, a recombinant human granulocyte colony stimulating factor(G-CSF).Indian guidelines for biosimilars are also an important part of the study. India is a highly developed country for generic drug and the national conditions are similar to China. In order to get some experiences from India, the study selected the country innovatively.The study not only offers useful information and advices for the regulatory body, but also provides practical guidance for themanufacturer. The potential global market for emerging biosimilars is obviously anappealing niche, Chinese companies should make effort to gain aportion of the market.