Multi-therapy Drugs: Opportunities for Generics & Biosimilars

  • October 2011
  • -
  • Espicom Business Intelligence

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 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 (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.

Table Of Contents


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
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
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 and 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
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
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 and 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 and US$ Million) ...... 21
Rituxan/MabThera Sales, 2009-2016 (CHF and US$ Million) ..... 25
Herceptin US Patents . 29
Herceptin Sales, 2009-2016 (CHF and US$ Million) ...... 30
Erbitux Sales by Company, 2009-2016 (EUR and 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 and US$ Million) .... 46
Product US Patents ..... 48
Sutent Sales, 2009-2016 (US$ Million) . 49
Product US Patents ..... 51
Nexavar Sales, 2009-2016 (EUR and US$ Million) .. 52
Velcade US Patents ..... 55
Velcade Sales by Company, 2009-2016 (US$ Million) ..... 56
Enbrel US Patents 60
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 (Â¥ Billion and US$ Million) ... 94
Cymbalta US Patents .. 97
FDA Tentative ANDA Approvals for Duloxetine ....... 98
Cymbalta Sales, 2009-2016 (US$ Million) .... 99
Viagra and 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
MULTI-THERAPY DRUGS: OPPORTUNITIES FOR GENERICS and BIOSIMILARS

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

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