ReportsnReports - Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars

Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars

The generic injectables sector exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. This critical new report evaluates the markets, players and products in detail.

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As companies seek new ways to gain a competitive edge in maturing generics markets, injectables have become increasingly desirable to the major players. Companies like Teva, Sandoz, Mylan, Hospira and Hikma have all increased their presence in the injectables sector through acquisitions in the last couple of years. And interest has not been limited to established generic companies, as pharmaceutical majors like Pfizer have also become attracted to the generic injectables market.

High risks, high reward

This is hardly surprising with a global injectables market in the region of US$120 billion. While the lion’s share remains with the innovative industry for the time being, the generic injectables sector already exceeds US$11.2 billion and numerous high-value injectable products will face patent expiry in major markets over the next decade. But, many of the big sellers are biological products and biosimilar approvals will only be possible for a few companies. Gaining regulatory approval in developed markets is more complex for biosimilars. For companies who are able to navigate the approval process, the sector for biosimilars is inherently different to the traditional generics market. Market acceptance remains a big challenge and the take-up of biosimilars in Europe 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 unlikely to exit the market as they may previously have done when faced with a flood of bioequivalent generics.

Is a biosimilar market inevitable?

The fact remains that the generic drugs sector must either respond vigorously or rely on a diminishing number of non-biological products. Progress to developing a biosimilar market to date has been patchy and slow, and few competitive therapies are beyond early-stage research. But accessing the fast-growing hospital market will be essential. Health payers, the branded industry and investment community will all be watching developments closely.

A complete analysis packed with market facts,
product forecasts to 2016 and detailed company evaluations

About the author: The report has been researched and written by Espicom’s Senior Pharmaceuticals Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include Injectable Generic Drugs: Prospects and Opportunities, Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs, and Ophthalmology Drug Futures.

Table Of Contents

FOREWORD . 1

EXECUTIVE SUMMARY  3

OVERVIEW . 4

INJECTABLE DRUGS MARKET. 4
European Markets  6
Biosimilars Approved in the EU . 7
Austria  8
Belgium  8
Denmark  9
France . 11
Germany  11
Italy  12
Netherlands  14
Spain . 15
Sweden  16
Switzerland . 17
United Kingdom . 17
US Market . 21

MAJOR COMPETITORS  23

CANCER . 27

HORMONAL THERAPIES . 27
Faslodex (fulvestrant). 27
Mode of Action  27
Approvals  27
Lifecycle Development  28
Competition within the Marketplace  28
Patents . 29
Generic Company Activity  29
Market Outlook . 29
Zoladex (goserelin) . 31
Mode of Action  31
Approvals  31
Competition within the Marketplace  32
Breast Cancer .32
Prostate Cancer .33
Patents . 33
Generic Company Activity  33
Europe . 33
North America . 34
Market Outlook . 34

CHEMOTHERAPY  36
Eloxatin (oxaliplatin). 37
Mode of Action . 37
Approvals  37
Competition within the Marketplace . 37
Patents . 38
Generic Company Activity  38
The ‘874 Patent Litigation: At Risk Launches and Subsequent Withdrawals . 38
Europe . 40
Market Outlook . 41
Taxotere (docetaxel)  42
Mode of Action . 42
Approvals  42
Competition within the Marketplace . 43
Patents . 43
Generic Company Activity  44
Europe . 44
US . 46
Market Outlook . 46
Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound)  48
Mode of Action . 48
Approvals  48
Lifecycle Development  48
Competition within the Marketplace . 49
Patents . 49
Market Outlook . 50
Alimta (pemetrexed)  51
Mode of Action . 51
Approvals  51
Lifecycle Development  52
Competition within the Marketplace . 52
Patents . 52
Generic Company Activity  52
Market Outlook . 53
Velcade (bortezomib)  54
Mode of Action . 54
Approvals  54
Lifecycle Development  55
Competition within the Marketplace  55
Patents . 55
Generic Company Activity  56
Market Outlook . 56

MONOCLONAL ANTIBODIES  58
Rituxan/MabThera (rituximab) . 58
Mode of Action  58
Approvals  59
Lifecycle Development  60
Competition within the Marketplace  60
Patents . 61
Biosimilar Activity . 61
Market Outlook . 61
Herceptin (trastuzumab) . 63
Mode of Action  63
Approvals  63
Lifecycle Development  64
Competition within the Marketplace  64
Breast Cancer .64
Gastric Cancer 65
Patents . 65
Biosimilar Activity . 65
Market Outlook . 65
Avastin (bevacizumab)  67
Mode of Action  67
Approvals  67
Lifecycle Development  68
Competition within the Marketplace  69
Patents . 69
Biosimilar Potential  69
Market Outlook . 69
Erbitux (cetuximab)  71
Mode of Action  71
Approvals  71
Lifecycle Development  71
Competition within the Marketplace  72
Patents . 72
Biosimilar Activity . 72
Market Outlook . 72\

SUPPORTIVE THERAPIES  74
G-CSF . 74
Neupogen (filgrastim) . 74
Mode of Action . 74
Approvals  75
Competition within the Marketplace . 75
Patents . 76
Biosimilar Activity  76
EU . 76
US . 77
Market Outlook . 78
Neulasta (pegfilgrastim) . 79
Mode of Action . 79
Approvals  79
Competition within the Marketplace . 80
Patents . 80
Biosimilar Activity  80
Market Outlook . 80

HAEMATOLOGY  82

ERYTHROPOIETIN . 82
Epogen/Eprex (epoetin alfa) . 83
Mode of Action . 83
Approvals  83
Competition within the Marketplace . 83
Patents . 84
Biosimilar Epoetin  84
EU . 84
US . 85
Market Outlook . 86
Aranesp (darbepoetin alfa)  87
Mode of Action . 87
Approvals  87
Lifecycle Development  87
Competition within the Marketplace . 88
Patents . 88
Biosimilar Development  88
Market Outlook . 89
NeoRecormon (epoetin beta) . 90
Mode of Action . 90
Approvals  90
Competition within the Marketplace . 91
Market Outlook . 91
Mircera (methoxy polyethylene glycol-epoetin beta) . 92
Mode of Action  92
Approvals  92
Competition within the Marketplace  92
Market Outlook . 92

THROMBOSIS . 94
Lovenox/Clexane (enoxaparin) . 94
Mode of Action  94
Approvals  94
Competition within the Marketplace  95
Patents . 95
Generic Company Activity  95
Momenta & Sandoz file enoxaparin suit against Teva 96
Market Outlook . 96
IMMUNOLOGY  98

MULTIPLE SCLEROSIS  98Copaxone (glatiramer acetate)  100
Mode of Action . 100
Approvals . 100
Lifecycle Development . 100
Competition within the Marketplace . 101
Patents  101
Generic Company Activity . 101
Sandoz and Momenta  101
Mylan and Natco Pharma  102
Market Outlook  102
Avonex (interferon beta-1a)  104
Mode of Action . 104
Approvals . 104
Lifecycle Development . 104
Competition within the Marketplace . 104
Patents  105
Market Outlook  105
Rebif (interferon beta-1a) . 107
Mode of Action . 107
Approvals . 107
Lifecycle Development . 107
Competition within the Marketplace . 108
Market Outlook  108
Betaferon/Betaseron & Extavia (interferon beta-1b)  110
Mode of Action . 110
Approvals  110
Lifecycle Development  111
Competition within the Marketplace . 111
Patents . 111
Market Outlook . 111
Tysabri (natalizumab)  113
Mode of Action . 113
Approvals  113
Lifecycle Development  114
Competition within the Marketplace . 114
Patents . 114
Market Outlook . 114

RHEUMATOID ARTHRITIS. 116
Enbrel (etanercept) . 117
Mode of Action . 117
Approvals  118
Competition within the Marketplace . 119
Patents . 119
Biosimilar Activity  119
Merck & Co  119
Avesthagen  120
Protalix BioTherapeutics . 120
Simcere  120
Market Outlook . 120
Humira (adalimumab) . 122
Mode of Action . 122
Approvals  122
Competition within the Marketplace . 123
Patents . 123
Biosimilar Activity  123
Market Outlook . 124
Remicade (infliximab)  125
Mode of Action . 125
Approvals  125
Competition within the Marketplace . 126
Patents . 126
Biosimilar Activity  127
Market Outlook . 127

INFECTION  129
Merrem/Meropen (meropenem)  129
Mode of Action . 129
Approvals . 129
Competition within the Marketplace . 130
Generic Approvals . 130
Market Outlook  131
Zosyn/Tazocin (piperacillin+tazobactam) . 133
Mode of Action . 133
Approvals . 133
Competition within the Marketplace . 133
Patents  134
Generic Approvals . 134
Market Outlook  137
Primaxin (imipenem+cilastatin sodium)  138
Mode of Action . 138
Approvals . 138
Competition within the Marketplace . 138
Generic Approvals . 138
Market Outlook  139
Cubicin (daptomycin)  141
Mode of Action . 141
Approvals . 141
Competition within the Marketplace . 142
Patents  142
Generic Company Activity . 142
Market Outlook  143
Tygacil (tygecycline) . 144
Mode of Action . 144
Approvals . 144
Competition within the Marketplace . 144
Patents  144
Generic Company Activity . 145
Market Outlook  145
Synagis (palivizumab)  147
Mode of Action . 147
Approvals . 147
Competition within the Marketplace . 147
Patents  147
Market Outlook  148
PegIntron (peginterferon alfa-2b)  149
Mode of Action . 149
Approvals  149
Competition within the Marketplace . 149
Patents . 150
Biosimilar Activity  150
Market Outlook . 150
Pegasys (pegylated-40K interferon alfa-2a)  152
Mode of Action . 152
Approvals  152
Competition within the Marketplace . 153
Patents . 153
Biosimilar Activity  153
Market Outlook . 154

COMPANY PROFILES . 1
ACTAVIS  1
Company Overview . 1
Manufacturing . 1
Major Developments  2
EC clears acquisition of control of Actavis by Deutsche Bank  2
Acquisitions & Agreements  2
Actavis plans biosimilars entry with help from Biopartners acquisition . 2
US development, supply and marketing agreement with Sagent  3
Co-development relationship with Bioluz  3
Litigation . 3
Oxaliplatin patent settlement  3
Products  3
AKORN  5
Company Overview . 5
Major Developments  5
Agreements  5
Injectable products agreement with Bioniche . 5
Premix product supply agreement with Fresenius . 5
Divestitures . 6
Akorn-Strides product portfolio sold to Pfizer  6
Products  6
Financials. 6

AMERICAN REGENT. 8
Company Overview . 8
Major Developments  8
Acquisitions  8
PharmaForce  8
Temporary suspension of manufacturing and distribution . 8
Products  9

AMPHASTAR PHARMACEUTICALS  12
Company Overview  12
Manufacturing . 12
Products . 12

APOTEX  14
Company Overview  14
Manufacturing . 14
Major Developments . 15
Agreements  15
Cangene acquires US commercialisation rights for HepaGam B . 15
Products . 15
Financials . 16

AUROBINDO PHARMA  18
Company Overview  18
Manufacturing  18
Major Developments . 18
Trident Life Sciences acquisition  18
Products . 19
Financials . 20

BEDFORD LABORATORIES . 21
Company Overview  21
Products . 21

CLARIS LIFESCIENCES  24
Company Overview  24
Manufacturing  24
Major Developments . 24
Marketing agreement with Pfizer . 24
Product withdrawals and FDA warning letter  24
Products . 25
Financials . 26

FRESENIUS KABI  27
Company Overview  27
Major Developments . 27
Acquisitions  27
APP . 27
Dabur . 28
Agreements  28
APP and Teva enter gemcitabine agreement  28
Products . 28
Financials . 31

HIKMA PHARMACEUTICALS . 33
Company Overview  33
Manufacturing  33
Major Developments . 34
Acquisitions & Agreements  34
Strategic partnership with Hubei Haosun  34
Baxter Healthcare’s Injectables Business 34
Strategic partnership with Unimark Remedies 34
Biosimilars agreement with Celltrion for MENA 34
Products . 35
Financials 36

HOSPIRA  37
Company Overview  37
Manufacturing . 37
Major Developments . 38
Acquisitions & Agreements  38
Javelin Pharma 38
Orchid Pharma 38
Biosimilars Agreement with Celltrion .39
Litigation . 39
Oxaliplatin patent settlement 39
Precedex (dexmedetomidine) lawsuits .39
FDA Warning Letter . 39
Products . 40
Biosimilars . 43
Financials 43

MYLAN . 44
Company Overview  44
Manufacturing . 44
Major Developments . 45
Bioniche Injectable Business Acquisition  45
Mylan Withdraws Marketing Application for Docetaxel . 46
Products . 46
Financials 47

PADDOCK LABORATORIES  48
Company Overview  48
Products . 48

SAGENT PHARMACEUTICALS . 49
Company Overview  49
Major Developments . 49
Sagent Pharmaceuticals announces initial public offering .49
Claris Lifesciences’ products withdrawn .50
Agreements  50
Exclusive collaboration with Actavis 50
Products . 50
Financials 51

SANDOZ  52
Company Overview  52
Manufacturing  52
Major Developments . 52
Acquisitions  52
Ebewe Pharma injectables business . 52
Litigation . 53
Generic Copaxone litigation  53
Momenta & Sandoz file enoxaparin suit against Teva . 53
Products . 53
Biosimilars . 55
Rituximab Phase II trial  55
Marketed biosimilar products  56
Financials . 56

STRIDES ARCOLAB . 57
Company Overview  57
Manufacturing  57
Major Developments . 58
Acquisitions & Agreements  58
Strides gains controlling stake in Inbiopro. 58
Strides acquires injectable facility in Brazil from Aspen  58
Strides & Aspen restructure oncology partnership . 58
Pfizer and Strides collaborate on generics . 58
Products . 59
Financials . 59

SUN PHARMA  61
Company Overview  61
Manufacturing  61
Major Developments . 62
Acquisitions & Agreements  62
Merck & Co and Sun form emerging markets joint venture . 62
Caraco Laboratories . 62
Litigation . 62
Court ruling stops Sun Pharma’s oxaliplatin sales . 62
Products . 63
Financials . 64

TEVA PHARMACEUTICAL INDUSTRIES . 66
Company Overview  66
Strategic Review . 66
Manufacturing  67
Major Developments . 68
Acquisitions  68
ratiopharm .68
Litigation . 68
Eli Lilly gains pemetrexed patent victory 68
Oxaliplatin patent settlement 68
Products . 68
Biopharmaceuticals and Biosimilars 71
Financials 72

WOCKHARDT . 73
Company Overview  73
Manufacturing . 73
Major Developments . 74
Divestitures . 74
Wockhardt sells its German business 74
Products . 74
Financials 75
Appendix I: FDA ANDA Approvals . 77
Appendix II: UK Injectable Generic Approvals . 84

SOURCES . 98
Espicom Sources . 98
Others . 98

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