美国、欧盟和中国生物技术药物的比较

按照相同表达系统表达的相同氨基酸序列的产品视为同种产品,而不同表达系统表达的相同氨基酸序列的产品视为不同产品的原则,归纳总结了美国、欧盟和中国已批准上市的生物技术药物。美国FDA批准的以基因工程产品、抗体工程产品和细胞工程产品为主要代表的生物技术药物共79种(18种为大肠杆菌表达,8种为酵母表达,53种为哺乳动物细胞培养生产),其中基因重组蛋白质药物为64种。欧盟批准了49种基因重组酶、激素或细胞因子,11种基因重组治疗性抗体和5种基因重组疫苗。在欧美60％-70％的产品由哺乳动物细胞表达。中国批准了27种生物技术药物。比较了美国、欧盟和中国生物制药的特点。

Comparison of Approval Biomedicines among USA, EU and 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.