1. Multi-therapy Drugs: Opportunities for Generics & Biosimilars
ReportsnReports.com adds Espicom Limited Market Research Report “Multi-therapy Drugs:
Opportunities for Generics & Biosimilars’’ to its store.
Targeting multiple conditions is likely to increase a drug’s potential target audience and
result in large financial returns for the developing company. With annual sales counted in
billions of dollars, these blockbuster drugs are undoubtedly attractive to companies
developing generics and biosimilars.
The logic is simple: more indications result in a larger number of potential patients and,
consequently, greater revenue opportunities. Obviously this logic only works if there is
unmet clinical need and efficacy is demonstrated in each indication, so the number of drugs
approved for multiple indications is relatively small. But where multiple indications are
approved, annual sales can be counted in billions of dollars. The trend for developing
products for multiple indications has been particularly evident in biological pharmaceuticals
and has resulted in multi-billion dollar sales over a number of years. The commercial costs
of developing biosimilars are great. Better, then to have the possibility of multiple revenue
streams.
Use this new report to easily answer key business questions, such as:
 What is the latest position on extrapolating biosimilar approvals to other indications, and
what impact could this have on the sector?
 How is Big Pharma’s attitude changing as the biosimilar market develops?
 Remicade (infliximab) generated sales of US$7.9 billion in 2010 and is indicated for 7
conditions –what are they?
 Which companies are known to be developing biosimilar versions of Pfizer/Takeda’s
Enbrel (etanercept)?
 How might new branded development in the multi-kinase sector affect the biosimilar
development of Bayer’s Nexavar (sorafenib)?
 What revenue generating lifecycle developments will offset the challenge of generic
competition for Roche’s Xeloda (capecitabine)?
 Assessing additional sales potential from a valuable product fit
The multi-therapy drugs market included in this report realised total sales in excess of
US$70 billion in 2010. It is, therefore, hardly surprising that many are being targeted by
generic companies for the development of either traditional bioequivalent generics, or as
targets for the next
wave of biosimilars.
The top selling multi-therapy drug in 2010 was Enbrel (etanercept), with sales reported
separately by Amgen, Pfizer and Takeda amounting to a total of US$7,850 million.
Remicade (infliximab) was a close second, with sales reported by Johnson & Johnson and
Merck & Co totalling US$7,581 million in 2010. In third place was Abbott’s Humira

2. (adalimumab), with sales of US$6,738 million; while Roche reported global sales of
Rituxan/MabThera (rituximab) worth US$6,094 million in 2010.
While the top five in terms of sales in 2010 were biologicals, a number of small molecule
multi-therapy drugs have established a place among the market leaders and are worthy of
attention as they will not face the same regulatory obstacles of biosimilars. These include
AstraZeneca’s Seroquel franchise, with revenue of US$5,302 million; Otsuka/Bristol-Myers
Squibb’s Abilify (aripiprazole) with sales reported by Otsuka amounting to US$4,266 million;
and Novartis’ Glivec/Gleevec (imatinib) with sales of US$4,265 million.
Generic and biosimilar opportunities: high risk, high reward?
With annual sales counted in billions of dollars, these blockbuster drugs are undoubtedly
attractive to companies developing generics and biosimilars. Competition is often fierce for
bioequivalent generics of the big sellers. Consequently, companies are likely to be vying for
a relatively small slice of the market. Nonetheless, when branded sales are counted in
billions of dollars, companies could still make a significant return even with generic price
erosion.
The market for biosimilars is inherently different to the traditional generics market. Market
acceptance remains a big challenge and the take up of biosimilars in Europe to date has
been relatively slow. Not only will companies need to convince healthcare providers that
biosimilar drugs are as good as the originator products, they will also have to compete with
the originator companies who are less likely to exit the market than if faced with a flood of
bioequivalent generics.
Biosimilar approval for multiple indications: extrapolation or additional trials?
One question that has yet to be fully answered with regard to multi-therapy drugs is
whether biosimilar approval for one indication will automatically lead to approval for all
indications associated with the reference product.
In the EU – so often the leading player in biosimilar regulation – the current position seems
a little vague. In November 2010, the EMA discussed extrapolation in its draft guideline on
similar medicinal products containing monoclonal antibodies (MAbs:
EMA/CHMP/BMWP/403543/2010). The guideline suggested the possibility of extrapolation of
clinical efficacy and safety data to other indications of the reference MAb, based on the
overall evidence of biosimilarity. However, the reality is unlikely to be simple, particularly
when the reference product is approved in unrelated indications.
The final guideline has yet to be published and a year later the subject of extrapolation
remains a major topic of discussion. In the meantime, companies are hedging their bets and
conducting comparative studies of their biosimilar MAbs in more than one indication.
About the Author
The report has been researched and written by Espicom Senior Analyst, Karen Holmes.
Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her
recent studies include
Hospital Injectable Drugs: Future Prospects for Generics and Biosimilars
Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs
Ophthalmology Drug Futures.

3. Table Of Contents
FOREWORD . 1
EXECUTIVE SUMMARY 3
OVERVIEW . 5
Lifecycle Development and New Indications . 5
Realising Additional Sales Potential 7
Rituximab: Multiple Indications from Oncology to Immunology . 8
Sildenafil: One Active Ingredient, Two Distinctly Branded Indications . 9
Generic and Biosimilar Opportunities . 9
Biosimilar Approval for Multiple Indications: Extrapolation or Additional Trials? . 10
US Patent Expiries 11
PRODUCT ANALYSIS . 12
ANTI-METABOLITES . 13
Alimta (pemetrexed) 13
Mode of Action 13
Approvals 13
Lifecycle Development 14
Competition within the Marketplace 14
Patents . 15
Generic Company Activity 15
Market Outlook . 15
Xeloda (capecitabine) 17
Mode of Action 17
Approvals 17
Lifecycle Development 19
Competition within the Marketplace 19
Colorectal Cancer 19
Breast Cancer .19
Gastric Cancer 20
Patents . 20
Generic Company Activity 20
Market Outlook . 20
MONOCLONAL ANTIBODIES 22
Rituxan/MabThera (rituximab) . 22
Mode of Action 22
Approvals 22
Lifecycle Development 24
Competition within the Marketplace 24
Patents . 24
Biosimilar Activity 24
Market Outlook . 25
Herceptin (trastuzumab) 27
Mode of Action . 27
Approvals 27
Lifecycle Development 28
Competition within the Marketplace . 28
Breast Cancer . 28

4. Gastric Cancer . 29
Patents . 29
Biosimilar Activity 29
Market Outlook . 30
Erbitux (cetuximab) 32
Mode of Action . 32
Approvals 32
Lifecycle Development 32
Competition within the Marketplace . 33
Patents . 33
Biosimilar Activity 33
Market Outlook . 33
Avastin (bevacizumab) 35
Mode of Action . 35
Approvals 35
Lifecycle Development 36
Competition within the Marketplace . 37
Patents . 37
Biosimilar Potential . 37
Market Outlook . 37
PROTEIN KINASE INHIBITORS . 39
Glivec (imatinib) . 39
Mode of Action . 39
Approvals 39
Lifecycle Development 40
Competition within the Marketplace . 41
Patents . 41
Generic Company Activity 41
Market Outlook . 42
Tarceva (erlotinib) . 43
Mode of Action . 43
Approvals 43
Lifecycle Development 44
Competition within the Marketplace 44
Patents . 44
Generic Company Activity 45
Market Outlook . 45
Sutent (sunitinib) . 47
Mode of Action 47
Approvals 47
Lifecycle Development 47
Competition within the Marketplace 48
Patents . 48
Generic Company Activity 48
Market Outlook . 49
Nexavar (sorafenib) . 50
Mode of Action 50
Approvals 50
Lifecycle Development 51

5. Competition within the Marketplace 51
Patents . 51
Generic Company Activity 51
Market Outlook . 52
OTHER ANTINEOPLASTIC AGENTS . 53
Velcade (bortezomib) 53
Mode of Action 53
Approvals 53
Lifecycle Development 54
Competition within the Marketplace 54
Patents . 54
Generic Company Activity 55
Market Outlook . 55
IMMUNOSUPPRESSANTS . 57
Enbrel (etanercept) . 58
Mode of Action 58
Approvals 59
Competition within the Marketplace 60
Patents . 60
Biosimilar Activity . 60
Merck & Co 60
Avesthagen .61
Protalix BioTherapeutics 61
Simcere 61
Market Outlook . 61
Remicade (infliximab) 63
Mode of Action . 63
Approvals 63
Competition within the Marketplace . 64
Patents . 64
Biosimilar Activity 65
Market Outlook . 65
Humira (adalimumab) . 67
Mode of Action . 67
Approvals 67
Competition within the Marketplace . 68
Patents . 68
Biosimilar Activity 68
Market Outlook . 69
Cimzia (certolizumab pegol) . 70
Mode of Action . 70
Approvals 70
Lifecycle Development 71
Competition within the Marketplace . 71
Patents . 71
Biosimilar Potential . 71
Market Outlook . 72
Actemra (tocilizumab) . 73
Mode of Action . 73

6. Approvals 73
Lifecycle Development 74
Competition within the Marketplace . 74
Biosimilar Potential . 74
Market Outlook . 74
Afinitor/Zortress (everolimus) . 76
Mode of Action . 76
Approvals 76
Lifecycle Development 77
Competition within the Marketplace . 77
Renal Cell Carcinoma . 77
Breast Cancer . 77
Patents . 78
Generic Company Activity 78
Market Outlook . 78
Tysabri (natalizumab) 80
Mode of Action 80
Approvals 80
Lifecycle Development 81
Competition within the Marketplace 81
Patents . 81
Market Outlook . 81
NERVOUS SYSTEM 83
Lyrica (pregabalin) 84
Mode of Action 84
Approvals 84
Lifecycle Development 84
Competition within the Marketplace 85
Patents . 85
Generic Company Activity 85
Market Outlook . 86
Seroquel (quetiapine) 87
Mode of Action 87
Approvals 87
Lifecycle Development 88
Competition within the Marketplace 88
Patents . 89
Generic Company Activity 89
Seroquel XR .89
Seroquel IR 90
Market Outlook . 90
Abilify (aripiprazole) . 92
Mode of Action 92
Approvals 92
Lifecycle Development 93
Competition within the Marketplace 93
Patents . 93
Generic Company Activity 94
Market Outlook . 94

7. Cymbalta (duloxetine) . 96
Mode of Action 96
Approvals 96
Lifecycle Development 97
Competition within the Marketplace 97
Patents . 97
Generic Company Activity 98
Market Outlook . 98
OTHER 100
Viagra & Revatio (sildenafil) . 100
Mode of Action . 100
Approvals 100
Lifecycle Development 100
Competition within the Marketplace . 101
Patents . 101
Generic Company Activity 101
Market Outlook . 102
SOURCES . 104
Espicom Sources 104
Others 104
DIRECTORY . 105
Regulators. 105
Manufacturers . 105
INDEX 107
List of Tables
Summary of Drugs and Indications 5
Drug Sales, 2010 (US$ Million) 8
Drugs by US Patent Expiry 11
Alimta US Patents 15
Tentative ANDA Approval for Pemetrexed 15
Alimta Sales 2009-2016 (US$ Million) . 16
Xeloda US Patents 20
Xeloda Sales, 2009-2016 (SFr & US$ Million) 21
Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million) . 25
Herceptin US Patents 29
Herceptin Sales, 2009-2016 (CHF & US$ Million) 30
Erbitux Sales by Company, 2009-2016 (EUR & US$ Million) . 34
Avastin Sales by Company, 2009-2016 38
Glivec US Patents . 41
Glivec/Gleevec Sales, 2009-2016 (US$ Million) . 42
Tarceva US Patents 45
Tarceva Sales, 2009-2016 (SFr & US$ Million) 46
Product US Patents 48
Sutent Sales, 2009-2016 (US$ Million) . 49
Product US Patents 51
Nexavar Sales, 2009-2016 (EUR & US$ Million) 52
Velcade US Patents 55
Velcade Sales by Company, 2009-2016 (US$ Million) . 56
Enbrel US Patents . 60

8. Enbrel Sales by Company, 2009-2016 (US$ Million) 62
Remicade US Patents 64
Remicade Sales by Company, 2009-2016 (US$ Million) . 65
Humira US Patents . 68
Humira Sales by Company, 2009-2016 (US$ Million) 69
Cimzia Sales, 2009-2016 (US$ Million) . 72
Actemra/RoActemra Sales by Company, 2009-2016 75
Afinitor/Zortress US Patents . 78
Afinitor/Zortress Sales, 2009-2016 (US$ Million) 78
Tysabri Sales by Company, 2009-2016 (US$ Million) 81
Lyrica US Patents 85
FDA Tentative ANDA Approvals for Pregabalin 85
Lyrica Sales, 2009-2016 (US$ Million) . 86
Seroquel US Patents 89
FDA Tentative ANDA Approvals for Quetiapine XR . 90
FDA Tentative ANDA Approvals for Quetiapine IR 90
Seroquel Sales, 2009-2016 (US$ Million) . 91
Abilify US Patents . 93
Abilify Sales by Company, 2009-2016 (¥ Billion & US$ Million) . 94
Cymbalta US Patents . 97
FDA Tentative ANDA Approvals for Duloxetine . 98
Cymbalta Sales, 2009-2016 (US$ Million) 99
Viagra & Revatio US Patents . 101
EU Marketing Authorisations for Generic Sildenafil 102
FDA Tentative ANDA Approvals for Sildenafil . 102
Viagra/Revatio Sales, 2009-2016 (US$ Million) 103
List of Figures
Alimta Sales Trend 2007-2016 . 16
Xeloda Sales Trend, 2007-2016 . 21
Rituxan/MabThera Sales Trend, 2007-2016 . 26
Herceptin Sales Trend, 2007-2016 . 31
Erbitux Sales Trend, 2007-2016 . 34
Avastin Sales Trend, 2007-2016 38
Glivec/Gleevec Sales Trend, 2007-2016 . 42
Tarceva Sales Trend, 2007-2016 46
Sutent Sales Trend, 2007-2016 49
Nexavar Sales Trend, 2007-2016 . 52
Velcade Sales Trend, 2007-2016 . 56
Enbrel Sales Trend, 2007-2016 62
Remicade Sales Trend, 2007-2016 66
Humira Sales Trend, 2007-2016 69
Cimzia Sales Trend, 2008-2016 72
Actemra/RoActemra Sales Trend, 2008-2016 75
Afinitor/Zortress Sales Trend, 2009-2016 . 79
Tysabri Sales Trend, 2007-2016 . 82
Lyrica Sales Trend, 2007-2016 86
Seroquel Sales Trend, 2007-2016 . 91
BMS Abilify Sales Trend, 2007-2016 95
Otsuka Abilify Sales Trend, 2007-2016 . 95

9. Cymbalta Sales Trend, 2007-2016 99
Viagra/Revatio Sales Trend, 2007-2016 . 103
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