Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013

  • December 2013
  • -
  • Espicom Business Intelligence
  • -
  • 172 pages

The market for injectable generics has been through a period of consolidation over the last few years as the leading companies have increased their presence through acquisition. The major players include Hospira, Sandoz (Novartis), Hikma Pharmaceuticals, Fresenius Kabi and Teva Pharmaceutical Industries. But interest in generic injectables has not been limited to established generic companies, as pharmaceutical majors like Pfizer have also become attracted to the market.

This is hardly surprising with a global injectables market in the region of US$144 billion. While the lion’s share remains with the innovative industry for the time being, the generic injectables market is worth around US$12.2 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 will be far more complex for biosimilars than for chemical generics and will involve costly clinical trials. To date, only a handful of companies have gained regulatory approval for biosimilars in Europe, and the US is likely to remain elusive to all but a select few. Among these, as the only US-based company with approval for biosimilars in the EU, Hospira is well positioned to take advantage of the potential US market.

This report features in-depth reviews of 35 major products within specific therapy areas. Each product review examines mode of action, market approvals, competition, patents and market outlook, with tables and charts analysing revenue and including five-year forecasts and more (where available). In addition, the report analyses the major competitors such as Actavis, Frensenius Kabi, Hospira, Sandoz and more...

What this report covers:

Executive Summary
Injectable Drugs Market – Market Size and Opportunities
Cancer – Hormonal Therapies, Chemotherapy, Monoclonal Antibodies, Supportive Therapies
Diabetes
Haematology
Immunology – Multiple Sclerosis, Rheumatoid Arthritis
Infection
Major Competitors

The Injectable Generic and Biosimilar Drugs Report is the foolproof business resource for any industry executive that needs to fully understand the current products and major competitors of the injectable drugs market. The need for hard facts and statistics to back up everyday business decisions is essential and it is this report that can provide you with the answers.

Table Of Contents

FOREWORD 1
EXECUTIVE SUMMARY 3
INJECTABLE DRUGS MARKET 4
Market Size 4
Generic and Biosimilar Opportunities 5
CANCER 8
HORMONAL THERAPIES 8
Faslodex (fulvestrant) 8
Mode of Action 8
Approvals 8
Lifecycle Development 8
Competition within the Marketplace 8
Patents 9
Market Outlook 9
Generic Company Activity 10
Zoladex (goserelin) 11
Mode of Action 11
Approvals 11
Competition within the Marketplace 11
Breast Cancer 11
Prostate Cancer 12
Patents 12
Market Outlook 12
Generic Company Activity 13
Europe 13
North America 14
CHEMOTHERAPY 15
Eloxatin (oxaliplatin) 15
Mode of Action 15
Approvals 15
Competition within the Marketplace 15
Patents 16
Market Outlook 16
Generic Company Activity 17
The ‘874 Patent Litigation: At Risk Launches and Subsequent Withdrawals 17
Europe 18
Taxotere (docetaxel) 19
Mode of Action 19
Approvals 19
Competition within the Marketplace 19
Patents 19
Market Outlook 20
Generic Company Activity 20
Europe 20
US 21
Abraxane (paclitaxel protein-bound particles for injectable suspension; albumin-bound) 22
Mode of Action 22
Approvals 22
Competition within the Marketplace 22
Patents 23
Market Outlook 23
Generic Company Activity 24
Alimta (pemetrexed) 25
Mode of Action 25
Approvals 25
Lifecycle Development 25
Competition within the Marketplace 25
Patents 26
Market Outlook 26
Generic Company Activity 27
Velcade (bortezomib) 28
Mode of Action 28
Approvals 28
Competition within the Marketplace 28
Patents 28
Market Outlook 29
Generic Company Activity 30
MONOCLONAL ANTIBODIES 32
Rituxan/MabThera (rituximab) 32
Mode of Action 32
Approvals 32
Competition within the Marketplace 32
Patents 33
Market Outlook 33
Biosimilar Rituximab 34
Herceptin (trastuzumab) 35
Mode of Action 35
Approvals 35
Competition within the Marketplace 35
Breast Cancer 35
Gastric Cancer 36
Patents 36
Market Outlook 36
Biosimilar Trastuzumab 37
Avastin (bevacizumab) 38
Mode of Action 38
Approvals 38
Competition within the Marketplace 39
Patents 39
Market Outlook 39
Biosimilar Bevacizumab 40
Erbitux (cetuximab) 41
Mode of Action 41
Approvals 41
Competition within the Marketplace 41
Patents 42
Market Outlook 42
Biosimilar Cetuximab 43
SUPPORTIVE THERAPIES 44
G-CSF 44
Neupogen (filgrastim) 45
Mode of Action 45
Approvals 45
Competition within the Marketplace 45
Patents 45
Market Outlook 46
Biosimilar Filgrastim 46
Europe 46
USA 47
Rest of the World 48
Neulasta (pegfilgrastim) 49
Mode of Action 49
Approvals 49
Competition within the Marketplace 49
Patents 50
Market Outlook 50
Biosimilar Pegfilgrastim 51
DIABETES 52
Humulin (insulin [rDNA origin]) 53
Mode of Action 53
Approvals 53
Competition within the Marketplace 53
Market Outlook 53
Humalog (insulin lispro) 55
Mode of Action 55
Approvals 55
Competition within the Marketplace 55
Patents 55
Market Outlook 55
Lantus (insulin glargine) 57
Mode of Action 57
Approvals 57
Competition within the Marketplace 57
Patents 57
Market Outlook 58
Apidra (insulin glulisine) 59
Mode of Action 59
Approvals 59
Competition within the Marketplace 59
Patents 59
Market Outlook 60
Levemir (insulin detemir) 61
Mode of Action 61
Approvals 61
Competition within the Marketplace 61
Patents 61
Market Outlook 62
NovoRapid and NovoMix (insulin aspart) 63
Mode of Action 63
Approvals 63
Competition within the Marketplace 63
Patents 63
Market Outlook 64
Biosimilar Human Insulin 65
Europe and USA 65
Rest of the World 66
HAEMATOLOGY 67
Epogen/Eprex/Procrit (epoetin alfa) 68
Mode of Action 68
Approvals 68
Competition within the Marketplace 68
Patents 68
Market Outlook 69
Biosimilar Epoetin 70
EU 70
US 70
Aranesp (darbepoetin alfa) 72
Mode of Action 72
Approvals 72
Competition within the Marketplace 72
Patents 73
Market Outlook 73
Biosimilars in Development 74
Lovenox/Clexane (enoxaparin) 75
Mode of Action 75
Approvals 75
Competition within the Marketplace 75
Patents 75
Market Outlook 75
Generic Company Activity 76
Court of Appeals decision in enoxaparin suit 77
IMMUNOLOGY 78
MULTIPLE SCLEROSIS 78
Copaxone (glatiramer acetate) 80
Mode of Action 80
Approvals 80
Competition within the Marketplace 80
Patents 81
Market Outlook 81
Generics in Development 82
Sandoz and Momenta 83
Mylan and Natco Pharma 83
Avonex (interferon beta-1a) 84
Mode of Action 84
Approvals 84
Competition within the Marketplace 84
Patents 85
Market Outlook 85
Rebif (interferon beta-1a) 87
Mode of Action 87
Approvals 87
Competition within the Marketplace 87
Market Outlook 87
Betaferon/Betaseron and Extavia (interferon beta-1b) 89
Mode of Action 89
Approvals 89
Competition within the Marketplace 89
Patents 89
Market Outlook 89
Biosimilar Interferon Beta 90
RHEUMATOID ARTHRITIS 92
Enbrel (etanercept) 93
Mode of Action 93
Approvals 93
Competition within the Marketplace 93
Patents 93
Market Outlook 94
Biosimilar Etanercept 95
Humira (adalimumab) 97
Mode of Action 97
Approvals 97
Competition within the Marketplace 97
Patents 97
Market Outlook 98
Biosimilar Adalimumab 99
Remicade (infliximab) 100
Mode of Action 100
Approvals 100
Competition within the Marketplace 100
Patents 100
Market Outlook 101
Biosimilar Infliximab 103
INFECTION 104
Cubicin (daptomycin) 104
Mode of Action 104
Approvals 104
Competition within the Marketplace 105
Patents 105
Market Outlook 105
Generic Company Activity 106
Invanz (ertapenem) 108
Mode of Action 108
Approvals 108
Competition within the Marketplace 108
Patents 108
Market Outlook 109
Generic Company Activity 110
Tygacil (tygecycline) 111
Mode of Action 111
Approvals 111
Competition within the Marketplace 111
Patents 112
Market Outlook 112
Generic Company Activity 113
Synagis (palivizumab) 114
Mode of Action 114
Approvals 114
Competition within the Marketplace 114
Patents 114
Market Outlook 114
Biosimilar Development 115
PegIntron (peginterferon alfa-2b) 116
Mode of Action 116
Approvals 116
Competition within the Marketplace 116
Patents 116
Market Outlook 117
Pegasys (pegylated-40K interferon alfa-2a) 118
Mode of Action 118
Approvals 118
Competition within the Marketplace 118
Patents 118
Market Outlook 119
Biosimilar Interferon Alfa 120
MAJOR COMPETITORS 122
ACTAVIS 127
Products 127
Major Developments 128
Acquisitions and Agreements 128
Actavis completes acquisition of Warner Chilcott 128
GENERIC AND BIOSIMILAR INJECTABLE DRUGS
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Litigation 128
Generic Diprivan patent challenge 128
Generic Velcade patent challenge 128
AKORN 129
Products 129
Acquisitions and Agreements 129
Akorn completes acquisition of Kilitch Drugs (India) 129
Akorn acquires injectables from Lundbeck 129
AMERICAN REGENT 130
Products 130
AMPHASTAR PHARMACEUTICALS 132
Products 132
APOTEX 133
Products 133
Agreements 133
Stada Arzneimittel in-licenses Grastofil 133
AUROBINDO PHARMA 134
Products 134
CLARIS LIFESCIENCES 135
Products 135
Recent Developments 135
Claris Lifesciences completes transfer of its Infusion Business for India and Emerging Markets
to the joint venture with Otsuka Pharmaceutical and Mitsui 135
Claris Lifesciences to sell on its own in the US 136
DR REDDY’S LABORATORIES 137
Products 137
FRESENIUS KABI 138
Products 138
Product recalls 139
Fresenius Kabi recalls Benztropine Mesylate injection 139
Fresenius Kabi recalls single lot of magnesium sulphate 139
Acquisitions 139
APP acquires three products from Nexus 139
Agreements 139
Fresenius Kabi begins joint venture on IV generics in Indonesia 139
APP and Teva enter gemcitabine agreement 140
Litigation 140
APP settles with the Medicines Company on Angiomax patent litigation 140
HIKMA PHARMACEUTICALS 141
Products 141
GENERIC AND BIOSIMILAR INJECTABLE DRUGS
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Acquisitions and Agreements 142
Commercial supply contract with Unilife Medical Solutions 142
Hikma enters Ethiopian pharmaceutical market through joint venture with MIDROC Group 142
HOSPIRA 143
Products 143
Biosimilars 143
Acquisitions and Agreements 144
Hospira signs agreement with Q Core Medical for International distribution of Sapphire Infusion System 144
Hospira acquires API manufacturing and RandD facilities from Orchid 144
Litigation 145
Cubicin patent infringement lawsuit 145
MYLAN 146
Products 146
Acquisitions 146
Mylan’s acquires Agila from Strides Arcolab 146
Litigation 148
Mylan and Teva settle Copaxone patent litigation 148
SAGENT PHARMACEUTICALS 149
Products 149
Product recalls 150
Sagent Pharmaceuticals announces expanded recall of vecuronium bromide 150
Acquisitions and Agreements 151
Sagent Pharmaceuticals announces agreement to acquire remaining 50% interest in Chinese
manufacturing joint venture 151
Sagent announces amendment to supply agreement with Actavis 151
SANDOZ 152
Products 152
Biosimilars 153
Marketed biosimilar products 153
Etanercept Phase III trial 153
Litigation 154
Sandoz’s generic Copaxone does not infringe Teva’s patent 154
STRIDES ARCOLAB 155
Products 155
Agreements 157
Pfenex and Agila Biotech in joint venture to develop biosimilars for global market 157
Sale of Agila Specialties division to Mylan 157
Strides and Eli Lilly strategic partnership to deliver generic cancer medicines in emerging markets 157
Strides Arcolab sells generic pharmaceutical operations in Australia and Southeast Asia to Watson
Pharmaceuticals 157
SUN PHARMA 158
GENERIC AND BIOSIMILAR INJECTABLE DRUGS
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Products 158
Acquisitions and Agreements 159
Sun Pharma and Intrexon joint venture to develop new class of therapeutics for Ocular Diseases 159
Sun Pharma and Taro announce termination of proposed merger 159
Sun Pharma to acquire URL Generic from Takeda 159
TEVA PHARMACEUTICAL INDUSTRIES 160
Products 160
Biopharmaceuticals and Biosimilars 161
Litigation 162
Teva and Mylan settle patent dispute 162
Agreements 162
Teva and Lonza discontinue biologics joint venture 162
Teva terminates agreements with CureTech 162
Teva enters agreement with Handok 162
WOCKHARDT 163
Products 163
Appendix: FDA ANDA Approvals 164
Sources 171
Index 172

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