This report gives an overview of biologic regulations in China and Insight into the key drivers and resistors to biogeneric uptake in the China

1. Biosimilars: China Update
Published:September 2011
No.Of Pages:51
Price:US $ 1900
Introduction
Currently, there is no definition, guidance or pathway for biosimilars in China, with
domestically manufactured versions of biologics, known as biogenerics. Due to limited R&D
capabilities, most domestic companies manufacture simple biologics, although there is a
growing shift towards the development of both novel and biogeneric monoclonal antibodies
and second-generation biologics.
Features and benefits
* An overview of biologic regulations in China
* Insight into the key drivers and resistors to biogeneric uptake in the China
* Assessment of the key marketed and pipelines in the Chinese biogenerics market.
* Provides a snapshot of key major biogeneric players and the strategies they have
implemented.
Highlights
Poor enforcement of patent protection provides significant opportunities for domestic
companies. Manufacturers also benefit from low development costs as well as government
support. As a result, biogenerics are priced much lower in China compared to originators.
It is mandatory for biologics (and biogenerics) approved as “new drugs” (i.e. those that
reference a product not currently marketed in China), to undergo full Phase I–III clinical
trials. However, only Phase III clinical trials are required for biogenerics which reference a
product that is marketed domestically.
A protracted and complicated drug registration process increases regulatory approval
timelines, impacting market access, with further delays for drugs not manufactured
domestically. Also, despite many biogenerics being reimbursed, low purchasing power still
limits uptake in China.
Table Of Contents
EXECUTIVE SUMMARY
Introduction
Strategic scoping and focus
Datamonitor key findings
Biologic regulatory overview

2. Drivers and resistors for biologics uptake
Marketed and pipeline biologics
Key biologic players in the Chinese market
Related reports
CHINA – BIOLOGIC REGULATORY OVERVIEW
No biosimilars pathway yet exists in China
Regulatory approval criteria for biologics in China
CHINA – D RIVERS AND RESISTORS FACING BIOGENERICS IN CHINA
Drivers of biogeneric development in China
Patent protection is poorly enforced leading to opportunities for domestic biologics
manufacturers
Low development costs aid market entry
Government support of the domestic biopharmaceutical industry
Domestic companies enter partnerships to facilitate development of biologics for the
Chinese market
Drivers of biogenerics uptake in China
Cost-containment will drive uptake of biogenerics
Biogenerics are priced much lower in China compared to originators
Biogenerics are reimbursed as List B drugs on the NRDL
Resistors impacting biogeneric uptake in China
Protracted and complicated drug registration increases regulatory approval timelines,
impacting market access
Low purchasing power, a high proportion of out-of-pocket expenditure, and brand loyalty
limit access to biogenerics
CHINA – MARKETED AND PIPELINE BIOLOGICS
Biologics sales in China
Marketed biologics in China
Monoclonal antibodies are set to drive sales in the Chinese biologics market
Second-generation biologics
CHINA – KEY BIOLOGICS PLAYERS
CP Guojian Pharma
3SBio
Gan Lee Pharmaceuticals
Jiuyuan Gene
Shuanglu Pharmaceutical
Bibliography
Publication and online articles
Datamonitor reports
Appendix
Exchange rates used in this report

3. LIST OF TABLES
Table: Pipeline and marketed biogeneric monoclonal antibodies in China, 2011
Table: Snapshot of domestic biologic companies’ biologic and biogenerics portfolios, 2011
Table: Minimum numbers of patients enrolled in clinical trials for biologics applications in
China
Table: Patent expiry date for top 10 selling biologics in China
Table: Pharmaceutical companies engaged in biologics-related deals in China, 2009–11
Table: Examples of key biotech-university partnerships in China
Table: Biosimilar discount difference versus reference brand in key markets (%), 2010
Table: Biologics included on the 2004 and 2009 NRDLs in China
Table: Monoclonal antibodies developed and marketed by domestic companies in China,
2011
Table: Monoclonal antibody development deals in China, 2009–11
Table: Pipeline of domestically developed monoclonal antibodies in China, 2011
Table: Snapshot of domestic biologic companies’ biologic and biogenerics portfolios, 2011
Table: CPGJ – pipeline and marketed product portfolio, 2011
Table: Comparison of Yi Sai Pu to Enbrel and Qiang Ke, 2011
Table: 3SBio – pipeline and marketed product portfolio, 2011
Table: Gan Lee Pharmaceuticals – pipeline and marketed product portfolio, 2011
Table: Jiuyuan Gene – pipeline and marketed product portfolio, 2011
Table: Shuanglu Pharmaceutical – pipeline and marketed product portfolio, 2011
Table: Currency exchange rates, 2011
LIST OF FIGURES
Figure: Biosimilars approval pathways
Figure: Comparison of biosimilars guidelines across major markets, 2011
Figure: Key factors influencing biogeneric development and uptake in China
Figure: China’s central government policies in favor of biotech development, 2006–11
Figure: National biotech industrial zones in China
Figure: Comparison of treatment costs for selective biogenerics versus originator products in
China, 2011
Figure: Approval pathway for biologics and biogenerics in China
Figure: Number of approved drug registrations in China, 2006–09
Figure: Proportion of government and private health expenditure vs. personal disposable
income, in China and other major markets, 2009
Figure: Sales of erythropoietin and filgrastim in China and the total Asia Pacific region,
2006–10
Figure: Types of biologics in China, 2011
Figure: Number of marketed biologic products in China, 2010

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