The biopharmaceutical industry in China: history and future perspectives

Abstract

Biopharmaceuticals reflect the rapid progress achieved in modern biomedical research. This area has also become one of the main criteria for assessing the development level of biotechnology for a particular country. Although it has been only three decades since the first biopharmaceutical, recombinant human insulin, was licensed by the US Food and Drug Administration, the biopharmaceutical industry has become the fastest growing, most dynamic and technology-intensive sector in the biomedical field. Since the licensing of recombinant human interferon α1b in 1989, the biopharmaceutical industry in China has gone through initial developments and gradually entered a period of rapid growth. This paper provides an overview of the status and development trends of biopharmaceuticals in China, and compares them with those observed in developed countries.

Key words： biopharmaceuticals; antibodies; market trends; diseases; China; national regulatory agency

Acknowledgements

This work was supported by the National “Key Technologies for New Drug Innovation and Development” Program (2009ZX09307-001), and the National High-tech Research and Development Program (“863 Program”) (2007AA021601 and 2007AA021204).

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