TABLE OF CONTENTS

5 EXECUTIVE SUMMARY
5 Generics market
5 Biosimilars market

7 GENERICS MARKET DYNAMICS
9 Russia generics volume uptake
10 Russia generics value uptake
11 Russia generics market size

13 GENERICS DRIVERS AND RESISTORS
14 Despite reimbursement programs there are significant out-of-pocket costs
15 Import substitution policies aim to increase the share of domestically manufactured generics
16 Domestic GMP standards are poor but are set to improve
16 Lack of adequate pharmacovigilance puts patients at risk and reduces trust
16 Patients prefer branded generics
17 Generics to benefit from compulsory INN prescribing
17 Generics may benefit from simplified registration process
17 Key generics players

20 BIOSIMILARS MARKET DYNAMICS
20 Development costs and lack of regulation is attractive to biosimilar manufacturers
21 Biosimilars available in Russia
23 Russia presents challenges for monoclonal antibody manufacturers

26 BIBLIOGRAPHY

30 APPENDIX
30 About the author
LIST OF FIGURES

9 Figure 1: Russia generic volume uptake versus other key pharmaceutical markets (%), 2008–11
10 Figure 2: Russia generic value uptake versus other key pharmaceutical markets (%), 2008–11
11 Figure 3: Russia generics market size versus other key pharmaceutical markets ($bn), 2008–11
13 Figure 4: Key factors impacting generics uptake in Russia, 2010
20 Figure 5: Key factors impacting biosimilars uptake in Russia
24 Figure 6: Drivers of and resistors to biosimilar monoclonal antibody entry in Russia

LIST OF TABLES
7 Table 1: Generic volume/value uptake (%) and market size ($bn) in key pharmaceutical
markets including Russia, 2008–11.

9 Table 2: Generics volume and value uptake in different segments of the Russian
pharmaceutical market (%), 2010
21 Table 3: Biosimilars registered in Russia, 2009
23 Table 4: Examples of approved clinical trials in Russia for biosimilars during 2011–12