Keywords : biosimilar, Biopharmaceutical, Monoclonal Antibody, insulin analogue, somatropin, Intron A, Betaseron, Rebif, Pegasys
Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies – and some surprising names – are positioning themselves for market entry. Examining the market for companies The need for a settled market environment is essential if the growing numbers of biologic products losing patent protection in the next 5-10 years is to be exploited. However, progress is painfully slow...
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Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies – and some surprising names – are positioning themselves for market entry.
Examining the market for companies
The need for a settled market environment is essential if the growing numbers of biologic products losing patent protection in the next 5-10 years is to be exploited. However, progress is painfully slow and critical issues driving the market dynamic include:
Industry investment: a sign of confidence?
This report provides a detailed analysis of 50 companies active in the biosimilars field, many of which have declared their interest in 2011. The move may reflect a growing confidence that as regulatory provision for biosimilars increases, and as the pipeline of prospective products matures, then the prospect of actually being able to launch products grows more realistic.
The US continues to disappoint; Europe forges ahead
Despite President Obama’s health reform bill being passed in 2010, very little has happened. And the FDA’s cautious approach suggests little will happen in the immediate future. The much anticipated Guidance, expected in 2011 has failed to appear, and in May 2011 FDA published details for User Fees – a scheme that will not come into effect
(assuming it is passed by Congress) until 2013. Given that an untried regulatory system will not operate at the fastest speed then prospects of a US market for advanced biosimilars seem remote before 2015. In contrast, European regulators are revising their widely-adopted regulations in the light of experience, with a view to issuing revisions and guidance in 2012.
Developing markets may offer a profitable alternative
Developing markets with rising disposable incomes may present the medium-term prospect for biosimilars, since they combine a large target population with reduced operating costs. Many countries are following the EU model of regulation. Markets such as India and China have plenty of home-grown production capacity. Some companies
have sought to turn this capacity to their advantage, and have signed deals with Chinese/Indian producers for the development of products to be sold around the world.
This report provides a comprehensive insight to the market environment,
current and future products and the companies involved.
A complete examination of the regulatory situation in the US, Europe and emerging markets
Detailed assessment of current biosimilar products and developers with market share by product
- EPO
- G-CSF
- HGH
- Human Insulin
- Interferon (alfa & beta)
Identification and analysis of likely second wave of advanced biologics to come to the market
- Adalimumab
- Etanercept
- Infliximab
- Rituximab
- Trastuzumab
A review of operational issues that will affect the adoption of biosimilars including pricing/reimbursement, clinician attitudes and patient acceptance
The position, activity, products, pipeline and plans of 50 leading players in the field
The Challenge for Industry
The development of a biosimilar presents a series of challenges to traditional generic drug manufacturers seeking to enter the sector. To succeed, a company must have good financial backing. Small companies will be able to do the science, but the cost of product development and approval will generally exceed the resources of most chemical generic organisations. After this, there is the cost of marketing and post-market surveillance. There is little prospect in the EU and USA of biosimilars being sold unbranded and biosimilar developers will have to pay for the branding and the marketing of the products; a task for which many lack the funds, sales force and experience.
Corporate manoeuvring is seeing the competitive landscape change
Despite the challenges there has been an upsurge in company activity, most notably from the branded industry and from companies who have no current significant pharmaceutical interests. With the regulatory situation generally favourable to the branded industry, why are they interested?
There are three broad reasons why an originator would wish to become involved with biosimilars. Firstly, it would create a more diversified portfolio, an important consideration in an era of near-dry pipelines. Secondly, it would potentially allow for the development of expertise in the biologic area for companies which traditionally have limited involvement in biologics. Thirdly, it could potentially act as a “spoiler” operation by making the market environment more difficult for smaller biosimilar developers.
Among recent corporate developments
- Pfizer and Biocon announced a deal in October 2010 for the development and worldwide commercialisation of Biocon’s recombinant insulin products.
- Boehringer Ingelheim announced the establishment of a separate biosimilar business in September 2011.
- Amgen and Watson announced a deal for the development of biosimilar versions of non-Amgen biologic products in December 2011.
- Baxter and Momenta Pharmaceuticals announced a joint-venture for the development of biosimilars in December 2011.
- Biogen Idec announced a joint-venture deal with the Korean conglomerate, Samsung, for the development of biosimilars. This will not include biosimilars of Biogen Idec products.
- Fujifilm have indicated they will create a joint-venture for the development of biosimilars in 2012.
Competitive Assessment
50 Leading players reviewed
3SBio
Actavis
Amgen
Avesthagen
Bioclones
Biocon
Biogen Idec
Biolex Therapeutics
BioPartners
Bioton
Boehringer Ingelheim
Cangene
Cell Therapeutics
Celltrion
CIGB
Cinnagen
Cipla
CJ Corp
Claris Lifesciences
Dr Reddy’s
Elona Biotechnologies
Gennova Biopharmaceuticals
Getz Pharma
GTC Biotherapeutics
Hospira
Inno Biologics
Intas Biopharmaceuticals
Itero Biopharmaceuticals
LG Life Sciences
Merck & Co
MJ Biopharma
Momenta Pharmaceuticals
Mycenax Biotech
Mylan
Pfizer
Protalix
Reliance Life Sciences
Samsung
Sandoz
SciGen
Selexis
Shantha Biotechnics
Simcere/Shanghai Celgen
Stada Arzneimittel
Teva Pharmaceutical Industries
Three Rivers Pharmaceuticals
Viropro
Watson
Wockhardt
Zenotech Laboratories
Other reports and services in this sector are:
Biosimilars Business Review A quarterly round-up and review of the latest developments in this rapidly developing sector.
Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars (July 2011) The latest edition of Espicom’s best-selling injectables report focuses on hospital drugs in therapy areas such as cancer, thrombosis, rheumatoid arthritis and serious infection. The report examines the status, value and generic/biosimilar opportunity for over 30 high-growth injectable drugs.
World Generic Markets Each issue of our fortnightly business publication World Generic Markets will keep you in touch with the latest news on the companies, products and alliances that are shaping the global generic markets.
Global Biopharmaceutical Industry
TABLE OF CONTENTS
Foreword 1
Executive Summary 3
What is a biologic drug? 4
What’s in a name? 5
Biobetters 6
Why are Biosimilars an issue? 7
products in the ‘first wave’ 8
Erythropoietin (Epoetin, EPO) 8
What is it? 8
Who makes it? 8
Summary sales data 9
Company-specific sales data 13
Procrit/Eprex 13
Epogen/Aranesp 13
Neorecormon/Epogin 15
Current biosimilar activity 16
USA 16
Europe 16
Rest of the world 17
Human Growth Hormone (somatropin) 19
What is it? 19
Who makes it? 19
Summary sales data 20
Company specific sales data 23
Genotropin 23
Humatrope 23
Norditropin/other Novo Nordisk HGH products 24
Nutropin 24
Saizen/Serostim 25
Bio-Tropin/Tev-Tropin 26
Current biosimilar activity 27
USA 27
European Union 27
Rest of the world 27
G-CSF 29
What is it? 29
Who makes it? 29
Summary sales data 29
Company specific sales data 32
Neupogen/Neulasta 32
Neutrogin/Granocyte 33
Leukine 33
Current Biosimilar Activity 34
USA 34
European Union 34
Current biosimilar activity in the rest of the world 35
Human Insulin 37
What is it? 37
Who makes it? 37
Summary sales data 37
Company specific sales data 41
Novo Nordisk recombinant insulin products 41
sanofi-aventis recombinant insulin products: Lantus, Apidra 42
Current biosimilar activity 44
USA 44
European Union 44
Rest of the World 44
Interferon 46
What is it? 46
Who makes it? 46
Summary sales data 46
Company specific sales data 50
Merck & Co (formerly Schering-Plough) Interferon A (Intron A range) 50
Betaseron/Betaferon 51
Avonex 51
Rebif 52
Current Biosimilar Activity 53
USA 53
European Union 53
Rest of the World 53
Beyond the First wave 55
Etanercept 56
Amgen gains new patent for etanercept 56
Summary sales data – Amgen (USA & Canada) 57
Summary sales data – Pfizer (Outside USA & Canada) 57
Current Biosimilar activity 58
Monoclonal Antibodies 59
Adalimumab 62
Summary sales data 62
Current Biosimilar activity 63
Bevacizumab 64
Summary sales data 64
Current Biosimilar activity 64
Cetuximab 65
Summary sales data 65
Current Biosimilar activity 66
Infliximab 67
Summary sales data 67
Current Biosimilar activity 67
Rituximab 68
Summary sales data 68
Current Biosimilar activity 69
Dr Reddy’s: Reditux 69
Trastuzumab 70
Summary sales data 70
Current Biosimilar activity 70
WHY Are biosimilars an issue now? 71
Rising cost of healthcare 71
Is there a commercially viable market? 72
The price reduction of the biosimilar 72
Case Study: Biosimilar prices in the UK 73
Omnitrope 73
G-CSF 74
EPO 74
Patient population 75
Physician & patient acceptance 76
Regulatory attitude 77
National pricing & reimbursement policies 78
Interchangeability and substitutability 78
Norway makes biosimilar G-CSF switchable – then changes its mind 79
Extent of existing competition 80
Originator strategies to counter biosimilars 81
Global market size estimates, 2015 82
The Regulatory Situation in the USA 83
Overview of the US regulatory system 83
Hatch-Waxman is not generally applicable to biologics 84
The 505(b)(2) route 84
Enoxaparin 84
Another option: file a full BLA? 85
The Development of a US Biosimilar Pathway 87
The BCPIA 89
Approval will be no guarantee of interchangeability 90
Biosimilar market exclusivity 90
Reference product data exclusivity 90
White House seeks to lower data exclusivity period 91
Patent dispute resolution 91
User fees 93
Implementation of the BCPIA 95
Slow progress in 2011 98
The Regulatory Situation in Europe 100
Regulation of biosimilars 101
EMA Guideline Documents 102
Regulation of Monoclonal Antibodies 104
Regulations in Other Developed Markets 105
Australia 105
Canada 105
Japan 105
Singapore 106
Regulations in Developing markets 107
Why are these markets worth a look? 107
Brazil 108
India 109
Indonesia 110
Mexico 111
Saudi Arabia 112
Thailand 112
Vietnam 112
Who will be the players in the market? 113
Current Market Leaders 116
Sandoz 116
Omnitrope 116
Binocrit 116
Zarzio 116
Rituximab 116
Agreements 117
Sandoz’ Biosimilar Sales 117
Teva Pharmaceutical Industries 118
Tevagrastim/Neutroval 118
Rituximab 118
Teva’s Biosimilar Sales 119
Hospira 120
Retacrit 120
Nivestim 121
Distribution deal with Celltrion 121
Pliva sells biosimilar rights and facility to Hospira 121
The Indian Biosimilar Industry 122
Avesthagen 122
AVDESP 122
Avent 122
Kemwell Biopharma 123
BiotechCorp 123
Siegfried Biologics 123
Intas Pharmaceuticals 123
Biocon 124
Basalog 124
Insugen 124
Erypro 125
NUFIL 125
Other products 125
Pfizer and Biocon announce major insulin deal 125
Biocon takes 100% control of JV from CIMAB 125
Mylan and Biocon announce biosimilar deal 126
Biocon buys majority stake in German marketing company 126
Cipla 127
Mab Pharma/Bio Mabs 127
Claris Lifesciences 128
Dr Reddy‘s 129
Gennova Biopharmaceuticals 130
Intas Biopharmaceuticals 131
New mAb facility announced 131
Intas and Apotex sign G-CSF agreement 132
MJ Biopharma 133
Reliance Life Sciences 134
Shantha Biotechnics 135
Wockhardt 136
Zenotech Laboratories 137
Other Developers: Europe 138
BioPartners 138
Bioton 140
Gedeon Richter 142
Mochida 142
Stada Arzneimittel 142
Selexis 143
Stada Arzneimittel 144
EPO-zeta gains EU approval 145
Other Developers: Asia, Africa, Middle East 146
3SBio 146
Bioclones 148
Celltrion 149
Hikma and Celltrion enter biosimilars agreement for the MENA region 149
Egis to distribute Celltrion products 150
Cinnagen 151
CJ Corp 152
Getz Pharma 153
Inno Biologics 154
LG Life Sciences 155
Mycenax Biotech 156
Protalix 157
Samsung 158
SciGen 159
Simcere/Shanghai Celgen 161
Other Developers: Americas 162
Biolex Therapeutics 162
Cangene 163
Cell Therapeutics 164
CIGB 165
Elona Biotechnologies 166
GTC Biotherapeutics 167
Itero Biopharmaceuticals 169
Momenta Pharmaceuticals 170
Sandoz collaboration 170
Baxter joint venture 170
Mylan 171
Marketing Deal with Biocon 171
Three Rivers Pharmaceuticals 172
Viropro 173
Watson 174
Itero and Watson announce rFSH agreement 174
‘Big Pharma’ Companies 175
Amgen 175
Biogen Idec 175
Boehringer Ingelheim 176
Merck & Co 176
Former Insmed G-CSF products 177
Merck discontinues EPO project 177
Deal signed for etanercept 177
Pfizer 178
Insulin deal with Biocon 178
Sources 179
Directory 181
Regulators 181
Industry Associations 182
Manufacturers 183
Index 186
INDEX OF TABLES
Leading EPO Brands, World Sales, 2001-2010 (US$ millions) 9
Leading EPO Brands, % Change in Sales, 2002-2010 10
Leading EPO Brands, % of Subtotal, 2001-2010 11
J&J Sales of Procrit/Eprex, 2001-2010 (US$ millions) 13
Amgen Sales of Epogen/Aranesp, 2001-2010 (US$ millions) 14
Amgen EPO Patents in the USA 14
Roche Sales of Neorecormon/Epogin, 2002-2010 (SwF millions) 15
Biosimilar EPO: manufacturers' summary 18
Leading HGH Brands, World Sales, 2001-2010 (US$ millions) 20
Leading HGH Brands, % Change (US$ sales), 2002-2010 21
Leading HGH Brands, % of Subtotal, 2001-2010 21
Genotropin Sales, 2001-2010 (US$ millions) 23
Humatrope Sales, 2001-2010 (US$ millions) 24
Novo Nordisk HGH Sales, 2001-2010 (DKK millions) 24
Roche/Genentech HGH Sales, 2001-2010 (US$ millions) 25
Merck/Serono HGH Sales, 2001-2010 (US$ millions) 25
Biosimilar HGH: Manufacturers' Summary 28
Leading G-CSF Brands, World Sales, 2001-2010 (US$ millions) 29
Leading G-CSF Brands, % Change 2003-2010 30
Leading G-CSF Brands, % of Total, 2002-2010 30
Neupogen/Neulasta Sales, 2001-2010 (US$ billions) 32
Sales of Neutrogin/Granocyte, 2002-2010 (billion yen) 33
Biosimilar G-CSF: Manufacturers' Summary 36
Leading Human Insulin brands, World Sales, 2001-2010 (US$ millions) 38
Leading Human Insulin Brands, % Change, 2002-2010 38
Leading Human Insulin Brands, % of Subtotal, 2001-2010 39
Sales of Novo Nordisk Insulin Analogues, 2001-2010 (DKK million) 41
Sales of Humulin and Humalog, 2001-2010 (US$000s) 42
Biosimilar Human Insulin: Manufacturers' Summary 45
Leading Interferon Brands, World Sales, 2001-2010 (US$ millions) 46
Leading Interferon Brands, % of Subtotal, 2002-2010 47
Sales of Intron A and PEG-Intron, 2002-2010 (US$ millions) 50
Sales of Pegasys, 2002-2010 (SwF millions) 51
Sales of Betaseron/Betaferon, 2001-2010 (euro millions) 51
Sales of Avonex, 2001-2010 (US$ millions) 52
Sales of Rebif, 2001-2010 (US$ millions) 52
Biosimilar Interferons: Manufacturers' Summary 54
Summary, factors in favour of the development of biosimilars 71
UK NHS Price Comparison, Omnitrope v other HGH Brands, 2009-11 73
UK NHS Price Comparison, Ratiograstim v Neupogen, 2009-11 74
UK NHS Price Comparison, EPO 2010 74
UK NHS Price Comparison, EPO 2011 75
Estimated Global Biosimilar Market Size (EPO, G-CSF and HGH), 2015 (US$ millions) 82
CHMP General Biosimilar Guidelines 102
Other Relevant General Guidelines 103
CHMP Product-Specific Guidelines 103
Summary Requirements, Chemical Generic v Biosimilars 113
Summary of Biosimilar Manufacturers and Products 115
2010 US$ exchange rates used in this report 179
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