CHAPTER 1 EXECUTIVE SUMMARY 4
Scope of the report 4
Key findings 5

CHAPTER 2 BIOSIMILARS OVERVIEW 11
Biosimilars forecast analysis 11
Seven major markets - biosimilar forecast 11
The US - biosimilars forecast 12
Japan - biosimilars forecast 13
France - biosimilars forecast 14
Germany - biosimilars forecast 15
Italy - biosimilars forecast 16
Spain - biosimilars forecast 17
UK - biosimilars forecast 18
The case for biosimilars 19
Drivers of biosimilar uptake 20
The number and use of biologics on the market is set to grow, expanding the potential biosimilars market 20
The high cost of biologics will drive payers to look to biosimilars for cost-savings 20
Japan has introduced a biosimilars approval pathway 22
Resistors to biosimilar uptake 23
Absence of a biosimilars approval pathway in the US 23
Demonstrating comparability to the branded reference drug 23
Rebates and service agreements will present a barrier to biosimilars uptake 25

CHAPTER 3 GENERAL FORECASTING EVENTS AND ASSUMPTIONS 27
Key assumptions 27
Forecast biosimilar definition 29
Forecast rate and magnitude of baseline biosimilar uptake 29
Magnitude of biosimilar erosion based on generics volume uptake 29
Time to maximal biosimilar erosion of reference product 29
Forecast biosimilar pricing assumptions 30
Forecast entry of subsequent biosimilars 31
Two 'waves' of biosimilar entry forecast 31
Second biosimilar 'wave' will only erode market share of the first wave, not the reference brand 31
Forecast launches of pipeline biosimilars based on epoetin alpha and filgrastim development profiles 32
Biosimilar clinical development timelines 32
Negotiating the biosimilar regulatory landscape 33
Relative unknowns regarding regulatory issues in Japan and the US likely to delay biosimilar market entry 34
Biosimilars approval time in Japan likely to be the rate-limiting step 34
Market exclusivity in the US a contentious issue 34
Medicare billing in the US will affect uptake 36
Issues impacting biosimilar uptake 36
Second generation products will limit uptake 36
Device association will drive down biosimilar uptake 37
Hospital-retail divide and biosimilar uptake 38
Automatic substitution will drive up biosimilar uptake 39
Key biosimilars players 39
Generics and biosimilar strategies differ depending on company size 40
Branded companies poised to enter biosimilars market 41
Merck & Co. set to enter the biosimilars market in 2012 41
AstraZeneca and Eli Lilly commit to entering the biosimilars market 41
Daiichi-Sankyo in position to enter biosimilar market 42
Sanofi-Aventis and Pfizer eye up Wockhardt 42
GlaxoSmithKline and Johnson & Johnson say no to biosimilars 42

CHAPTER 4 BIOSIMILAR EPOETIN ALPHA FORECAST AND ASSUMPTIONS 44
Epoetin market overview 44
Biosimilar epoetin alpha forecast 46
Seven major markets - biosimilar epoetin alpha forecast 46
US - biosimilar epoetin alpha forecast 47
Japan - biosimilar epoetin alpha forecast 48
France - biosimilar epoetin alpha forecast 49
Germany - biosimilar epoetin alpha forecast 50
Italy - biosimilar epoetin alpha forecast 51
Spain - biosimilar epoetin alpha forecast 52
UK - biosimilar epoetin alpha forecast 53
Biosimilar epoetin alpha assumptions 54
Biosimilar epoetin alpha has already launched in Europe and will enter the US and Japan from 2013 54
Second wave of biosimilar epoetin alpha will launch in Europe from 2009, and in the US and Japan from 2014 55
Epoetin is a high margin product 55
Biosimilar epoetin alpha market share and speed of uptake 56
Molecule-specific factors for epoetin alpha have a net neutral effect on biosimilar uptake 56
Cost could be a considerable driver of biosimilar uptake in Germany, Spain and the UK 57
Aranesp will limit biosimilar epoetin alpha uptake 57
Hospital sales will slow biosimilar uptake 58
Market-specific characteristics will contribute to rate of uptake 59

CHAPTER 5 BIOSIMILAR FILGRASTIM FORECAST AND ASSUMPTIONS 60
Filgrastim market overview 60
Biosimilar filgrastim forecast 62
Seven major markets - biosimilar filgrastim forecast 62
US - biosimilar filgrastim forecast 63
Japan - biosimilar filgrastim forecast 64
France - biosimilar filgrastim forecast 65
Germany - biosimilar filgrastim forecast 66
Italy - biosimilar filgrastim forecast 67
Spain - biosimilar filgrastim forecast 68
UK - biosimilar filgrastim forecast 69
Biosimilar filgrastim assumptions 70
Neupogen is off-patent in Europe and Japan, and is set to lose patent protection in the US during 2013 70
Second wave of biosimilar filgrastim to enter market from 2010 72
Biosimilar filgrastim is likely to be heavily discounted 73
Biosimilar filgrastim market share and speed of uptake 73
Molecule-specific factors will drive biosimilar filgrastim uptake 74
Neulasta will limit biosimilar filgrastim uptake 74
Hospital sales will slow biosimilar uptake 75
Market-specific characteristics will contribute to rate of uptake 76

CHAPTER 6 BIOSIMILAR INTERFERON BETA FORECAST AND ASSUMPTIONS 77
Interferon beta market overview 77
Biosimilar interferon beta forecast 79
Seven major markets - biosimilar interferon beta forecast 79
US - biosimilar interferon beta 1a forecast 80
Japan - biosimilar interferon beta 1a forecast 81
France - biosimilar interferon beta 1a forecast 82
Germany - biosimilar interferon beta 1a forecast 83
Italy - biosimilar interferon beta 1a forecast 84
Spain - biosimilar interferon beta 1a forecast 85
UK - biosimilar interferon beta 1a forecast 86
Biosimilar interferon beta assumptions 87
Biosimilar interferon beta 1a anticipated to launch from 2012 87
The margin for biosimilar Avonex will be lower than that for epoetin alpha 87
The impact of biosimilar Copaxone, Rebif, and Betaseron will not be forecast 88
Biosimilar interferon beta market share and speed of uptake 88
Majority of biosimilar uptake will be derived from treatment-naïve patients and switching from non-responders 89
Hospital sales may include home deliveries 90
The multiple sclerosis market is highly cost-sensitive 91

CHAPTER 7 BIOSIMILAR INTERFERON ALPHA FORECAST AND ASSUMPTIONS 93
Interferon alpha market overview 93
Biosimilar interferon alpha forecast 95
Seven major markets - biosimilar interferon alpha forecast 95
US - biosimilar interferon alpha forecast 96
Japan - biosimilar interferon alpha forecast 97
France - biosimilar interferon alpha forecast 98
Germany - biosimilar interferon alpha forecast 99
Italy - biosimilar interferon alpha forecast 100
Spain - biosimilar interferon alpha forecast 101
UK - biosimilar interferon alpha forecast 102
Biosimilar interferon alpha assumptions 103
Interferon alpha 2a and 2b forecast to be combined 103
Patent protection for Intron-A and Roferon has expired in the seven major markets, paving the way for biosimilar incursion 103
Pricing could be used to incentivize biosimilar uptake 105
Biosimilar interferon alpha market share and speed of uptake 106
Molecule safety concerns may resist uptake 106
Device association will impact on uptake 107
Pegylated interferon alpha drives down the value of the biosimilar market 108
Retail dominance benefits biosimilar uptake 109
Smaller lesser known manufacturers will slow uptake 110

CHAPTER 8 BIOSIMILAR HUMAN GROWTH HORMONE FORECAST AND ASSUMPTIONS 111
Human growth hormone market overview 111
Biosimilar human growth hormone forecast 112
Seven major markets - biosimilar human growth hormone forecast 112
US - biosimilar human growth hormone forecast 113
Japan - biosimilar human growth hormone forecast 114
France - biosimilar human growth hormone forecast 115
Germany - biosimilar human growth hormone forecast 116
Italy - biosimilar human growth hormone forecast 117
Spain - biosimilar human growth hormone forecast 118
UK - biosimilar human growth hormone forecast 119
Biosimilar human growth hormone assumptions 120
One biosimilar human growth hormone product has launched in the EU and US 120
Biosimilar growth hormone launched at a 40% discount 121
Biosimilar human growth hormone market share and speed of uptake 121
Human growth hormone has a good safety profile 122
Uptake will largely be restricted to treatment-naïve population 122
Retail dominance will drive uptake 123
Formulation and device will be key to biosimilar success 123
Value-adds are important in the biosimilar human growth hormone market 124

CHAPTER 9 BIOSIMILAR INSULIN FORECAST AND ASSUMPTIONS 125
Insulin market overview 125
Standard human insulin market presents a poor commercial prospect for biosimilars 126
Modern insulin analogs offer greater commercial potential for biosimilar incursion 127
Lantus is the most lucrative biosimilar target 128
Biosimilar insulin-glargine forecast 129
Seven major market - biosimilar insulin-glargine forecast 129
US - biosimilar insulin-glargine forecast 130
Japan - biosimilar insulin-glargine forecast 131
France - biosimilar insulin-glargine forecast 132
Germany - biosimilar insulin-glargine forecast 133
Italy - biosimilar insulin-glargine forecast 134
Spain - biosimilar insulin-glargine forecast 135
UK - biosimilar insulin-glargine forecast 136
Biosimilar insulin-glargine assumptions 137
Biosimilar insulin-glargine will enter the seven major markets in 2014 137
Biosimilar insulin-glargine will erode market share only from Lantus 137
Second wave of biosimilar insulin-glargine will enter the following year 137
Insulin-glargine likely to launch at moderate discount 138
Biosimilar insulin-glargine market share and speed of uptake 138
Insulin-glargine is one of the simplest biologics 139
The need to adjust dosing presents a resistor to biosimilar substitution 139
Retail dominance will drive uptake 140
Brand loyalty on the part of physicians, and the need for value-adds will slow uptake 140
Biosimilars must enter the market with a strong device 141
BIBLIOGRAPHY 142
Publications and online articles 142
Conference literature 149
Datamonitor resources 149

APPENDIX 151

List of Tables
Table 1: Development and marketing of epoetin in the US and Europe, 2009 44
Table 2: Epoetin biosimilars with EMEA Marketing Authorization, 2009 54
Table 3: Epoetin alpha biosimilar pipeline, 2009 55
Table 4: Volume market split between short- and long-acting epoetin in the seven major markets, 2008 58
Table 5: Hospital-retail divide for branded epoetin alpha volume sales in the seven major markets, 2008 59
Table 6: Granulocyte colony stimulating factor (GCSF) biosimilars with European market authorization, 2008 71
Table 7: Filgrastim biosimilar pipeline, 2009 72
Table 8: Volume market split between short- and long-acting granulocyte colony stimulating factor (GCSF) in the seven major markets, 2005-08 75
Table 9: Hospital-retail divide for branded filgrastim volume sales in the seven major markets, 2008 76
Table 10: Market leading treatments for multiple sclerosis, 2009 77
Table 11: Biosimilar interferon beta pipeline, 2009 87
Table 12: Dominance of Avonex device use across the seven major markets, 2008 90
Table 13: Hospital-retail divide for branded interferon beta