中国生物类似药申报信息概要 | Biosimilar Applications in China

最近更新 | Last Updated:  2021-11-10

Biosimilar
生物类似药
Applicant
申请人
Ref. Product
参考药品
RPS
参考药开发商
Registered Patents
参考药登记专利1
Generic Certification
专利声明类型2
NMPA Approval
药监局批准日期
Launch Date
上市日期
贝伐珠单抗注射液
TQ-B2302
Chia Tai Tianqing Pharmaceutical
正大天晴
AVASTIN® (bevacizumab) Roche
罗氏
N/A Type 1 | 1类
托珠单抗注射液
BAT1806
Bio-Thera Solutions
百奥泰生物
ACTEMRA® (tocilizumab) Roche
罗氏
ZL02807784.9
ZL200480011401.1
ZL201511004468.9
Type 3 | 3类
Type 4.1 | 4.1类
Type 4.2| 4.2类
注射用曲妥珠单抗 Anhui Anke Biotechnology
安科生物
HERCEPTIN®
(trastuzumab)
Roche
罗氏
N/A Type 1 | 1类
地舒单抗注射液 Qilu Pharmaceutical
齐鲁制药
XGEVA®
(denosumab)
Amgen
安进
ZL201310052370.5 Type 3 | 3类
地舒单抗注射液
LY06006 / BA6101
Boan Biotech
博安生物
XGEVA®
(denosumab)
Amgen
安进
ZL201310052370.5 Type 3 | 3类
利拉鲁肽注射液 Huadong Medicine
华东医药
Victoza®
(liraglutide)
Novo Nordisk
诺和诺德
N/A Type 1 | 1类

1  China has implemented a patent linkage system in its amended patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic of China (2020)), and released the “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)” (药品专利纠纷早期解决机制实施办法 (试行), hereinafter, the “Measures”) on July 4, 2021. A patent registration platform has been established for the Marketing Authorization Holder (MAH) to register certain patents applicable to the approved drug product. For biologics, patents may be registered include those directed to the active pharmaceutical ingredient (API) sequence/structure information and medical use. 于 2021 年 6 月 1 日生效的新修正的《中华人民共和国专利法》第七十六条引入药品专利纠纷早期解决的有关规定(专利链接制度)。根据2021年7月4日发布的《药品专利纠纷早期解决机制实施办法(试行)》(以下简称《办法》),建立中国上市药品专利信息登记平台,用于相关药品专利信息登记与主动公开。生物制品可登记活性成分的序列结构专利、医药用途专利。

2  According to the Measures, for registered patents on approved biologics, biosimilar applicants need to make a patent certificate of any of the following types: (1) There is no relevant patent registered; (2) The registered patent has expired or has been declared invalid or the biosimilar applicant has a license; (3) There is a registered patent and the biosimilar applicant will not market the drug until expiration of the patent; and (4) There is a registered patent on the platform, but it should be invalid, or it does not cover the biosimilar. 根据《办法》,申请人提交生物类似药上市注册申请时需提交以下任一类型的专利声明: 1类声明:中国上市药品专利信息登记平台中没有被仿制药的相关专利信息;2类声明:中国上市药品专利信息登记平台收录的被仿制药相关专利权已终止或者被宣告无效,或者仿制药申请人已获得专利权人相关专利实施许可;3类声明:中国上市药品专利信息登记平台收录有被仿制药相关专利,仿制药申请人承诺在相应专利权有效期届满之前所申请的仿制药暂不上市;4类声明:中国上市药品专利信息登记平台收录的被仿制药相关专利权应当被宣告无效,或者其仿制药未落入相关专利权保护范围。