The status quo of Asia-Pacific biosimilar drugs and development strategy

On May 24, the 2011 biosimilar meeting was held in Shanghai. The theme of the conference was "Establishing the Development Strategy of Biosimilars". Nearly 200 people from pharmaceutical companies such as pfizer, Roche, Teva, and Merck & Co, CRO/CMO companies, financial institutions, pharmaceutical regulations, and government officials attended the conference. The conference is hosted by IBC. ICONplc, a global supplier of outsourced development services for the pharmaceutical, biotechnology and medical device industries, sponsored the conference.

Alan Sheppard, President of IMS Global Generics, analyzed the future of biosimilars. Alan said in the report that at present, the global biosimilar market has sales of 234.9 million US dollars, Sandoz, Teva and Hospira occupy 86.4% of the market (data as of August 2010). Data from 2005-2010 show that in the next five years, the total pharmaceutical market capacity in the Asia-Pacific region will reach US$175-520 billion, which is the same as in the European region; the average annual compound growth rate will remain 14%-17%. The region is the fastest growing region and is at a similar pace to Latin America. The top two China and India will reach 22%-25% and 15%-18% respectively. Before 2014, China will enter the top three of the pharmaceutical market (perhaps this year it can be achieved).

Faced with the complex and lengthy process for approval of new drug production in China, Dr. Zhou Xinhua, CEO of Shanghai Jiahe Biopharmaceuticals, believes this is not conducive to the development of domestic biosimilar drugs. High quality, low cost, and shortened product production time are the key to the production of biosimilars. Zhou Xinhua believes that at present, the bio-pharmaceutical boom provides a unique opportunity for the biotechnology/biopharmaceutical industry in China and even in the entire Asia-Pacific region. Thanks to the standard process introduced by the original research drug, the biosimilar wave is not only for the production of drugs and Circulation provides strict international standards for quality control, which also lays the foundation for the future improvement of preclinical and clinical biopharmaceutical R&D systems. In the long run, it is also beneficial to China's health industry, intellectual property protection and even the entire economic structure.

With regard to the research and development of biosimilar drugs, it is familiar with regional laws and regulations, access to optimized manufacturing processes, and appropriate marketing methods and other complex issues. As a matter of fact, companies have invested heavily in this field for a long time, but have had little success. According to the analysis, during the period of the biosimilar market, it generally needs 1-2 billion dollars. This has turned biosimilar into a high-growth, high-risk area. The conference comprehensively interpreted biosimilars from biosimilar trends: global trends and opportunities; latest regulatory guidelines; contractual legal issues and patent invalidations; safety, efficiency, substitution, and expansion of investment in emerging medical drug markets. The overall situation in the Asia-Pacific region and its macro-predictions for future development.

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