文档介绍：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
·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. as a
"significant milestone "The product approved is the recombinant colom stimulatng fador
higrastim-sndz (Zaro, Sandoz Novartis), whch has several clinical uses, induding aiding
recovery from neutropenia in cancer patients undergoing chemotherapy
·2019年2月:国内首个获批的生物类似药:利妥昔单抗
032023内部培训资补
B-conmiar Vema Webster
生物类似药的机遇与挑战(
GX PHARMA
国信医药
pportunities and Challenges in Biosimilar Development
2018年,全球生物类似药市场达38亿美金。市场主要驱动因素:重磅生物药
专利到期,降价,慢病率上升,政府和健康保险业的压价举措。综合因素后
仍然预期:2024年生物类似药市场将达到202亿美金;5年平均年复合增长率
在33%
Reference E
biosimilar market reached a value of USS Blion in 2018. This market is currently being drven by a
Adalimumab Umaru 2018 2016
number of factors such as patent expires of blockbuster biologica drugs, lower prices, rising prevalence of
Etanercept Enbrel 2015 2028
chronic diseases, and cost-saving initiates from governments and third -panty payers. Catalyzed by these
Infliximab Remicade 2015 2018
factors, the market is further proected to reach USS 2 Billion by 2024, growing at a CAGR of nearly 33%
Rituximab Mabthera 2013 2018
during the next five years
Bevacizumab Avastin
Trastuzumab Herceptin 2014 2019,未来5年,美国市场多达50种生物药的12年专卖权到期,是生物类似药厂家
Ranibuunab Lucenti 2022 2020
的目标
Over the next five years, the tweLve- year market excusiwty of many of the approximately 500 biologics Icensed
in the . will expire. These producs