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Multi-therapy Drugs: Opportunities for Generics & Biosimilars
Date:11/2/2011

NEW YORK, Nov. 2, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Multi-therapy Drugs: Opportunities for Generics & Biosimilars

http://www.reportlinker.com/p0662633/Multi-therapy-Drugs-Opportunities-for-Generics--Biosimilars .html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

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.

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 & 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 & 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


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SOURCE S .... 104
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