Comparison of Approval Biomedicines among USA,EU and China
HU Xian-wen CHEN Hui-peng TANG Zhong-ming MA Qing-jun( Beijing Institute of Biotechnology Beijing 100071, China Beijing Institute of Radiation Medicine Beijing 100850, China)
The approval biomedicines in USA, EU and China were summarized by these criteria: (1) regarded as one drug if some biomedicines have the same amino acid sequence and were produced by the same expression system; (2) regarded as different products if produced by different expression systems, even though the products have the same amino acid sequence. USA is the leader of biopharmaceutical industry, with 79 biotech drugs produced by genetic engineering, antibody technology or cytotechnology, being approved by FDA (18 products expressed by E. coli , 8 biotech drugs expressed by yeast, and 53 biomedicines produced by mammalian cell culture) , of which, 64 are recombinant therapeutic proteins. EMEA of EU has approved 49 recombinant enzymes, hormones or cytokines, 11 recombinant antibodies and 5 recombinant vaccines. About 60 % - 70 % of recombinant protein biopharmaceuticals are expressed by mammalian cell in USA and EU. There are 27 biotech drugs approved by SFDA in China. All of the approval biopharmaceuticals in USA, EU and China were listed and compared.
【CateGory Index】： TQ464