生物类似药研发精选.ppt

生物类似药的机遇与挑战 GX PHARMA 国信医药 Opportunities and Challenges in BiosImilar Development FDA Announces Approval of First Ever U.S ·206年,欧盟批准首个生物类似药:甘精胰岛素 Insulin Glargine) ·2012年,欧盟批准首个单克隆抗体生物类似药英利昔单抗 Infliximab) The EU has pioneered the regulation of biosimlars since the approval of the first one(the growth hormone somatropin) in 2006, and since then, the EUhas approved the highest number of biosim ars worldwide 2015年,美国FDA批准首个生物类似药:非格司亭 The first biosimlar product in the United States has been approved by the US Food and Drug Adminstration, in a move descnbed by the agencys drector, Janet Woodcock