4th World-China Biosimilars Forum

Background

The advances in biotechnology and huge market potential greatly stimulate the development of biosimilars. China has the largest number of R&D projects in the world, and only follows the United States and European Union in terms of core patents number.  The introduction of the pilot document of Guideline for Biosimiars R & D and Evaluation Technology by CFDA will help to regulate the R & D and application process of biosimialrs in China.
 
However, there are still many challenges in China biosimilars development. Although CFDA has issued the relevant regulations, the specific evaluation standards and related rules have not been introduced. The development process of biosimilars is much more complex than that of chemical generics while the requirements for biosimilars manufacturing are stricter.  Besides many biosmilar companies have entered into clinical phase. How to design a probable clinical trial protocol with low cost to ensure biosimilarity is a big challenge for them. 

 Based on the success of previous three continuous meetings, the 4th World China Biosimilars Forum2017 will provide a platform for representatives from leading bio-pharmaceutical companies, as well as experts from institutes and agencies to communicate with each other. They will have a deep discussion about the hot issues in biosimilar field, including biosimilars interchangeability, process stability, quality control, non-clinical and clinical evaluation, clinical trial protocol design, immunogenicity, immunotoxicity, manufacturing, cost and so on, which will help bio-pharmaceutical companies to deal with the challenges.