Monoclonal antibody:the corner stone of modern biotherapeutics

作     者：XIA Zhi-nan CAI Xue-ting CAO Peng 

作者机构：R&D Synageva Biopharma CorporationLexington MA 02421USA Laboratory of Cellular and Molecular BiologyJiangsu Province Institute of Traditional Chinese MedicineNanjing 210028China) 

出 版 物：《药学学报》 (Acta Pharmaceutica Sinica)

年 卷 期：2012年第47卷第10期

页      面：1275-1280页

核心收录：

学科分类：1007[医学-药学(可授医学、理学学位)] 1006[医学-中西医结合] 100706[医学-药理学] 100602[医学-中西医结合临床] 10[医学] 

主　　题：monoclonal antibody biotherapeutic biosimilar biobetter 

摘      要：Worldwide sales of biologic drugs exceeded 100 billion USD in *** 32% is from therapeutic monoclonal antibody(mAb).With many blockbuster biopharmaceutical patents expiring over the next decade,there is a great opportunity for biosimilar to enter the worldwide especially emerging *** European Medicines Agency(EMA) and Food and Drug Administration(FDA) have introduced regulatory frameworks for the potential approval of biosimilar mAb *** than providing a highly abbreviated path,as in the case for small molecule chemical drug,approval for biosimilar mAb will require clinical trial and the details will be very much on a case-by-case *** mAb is the dominant category of biologic drugs,mAb will be the focus of this ***,the United States(US) and European Union(EU) approved mAb and those in phase 3 trials will be reviewed,then strategies on how to win biosimilar competition will be reviewed.