Biosimilar Opportunities in an Evolving Market

  • August 2013
  • -
  • Espicom Business Intelligence
  • -
  • 113 pages

Biosimilars: another milestone passed

At the end of June 2013, the European Medicines Agency’s Committee for Medical Products for Human Use issued a positive opinion for the first biosimilar version of Johnson & Johnson’s infliximab for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. For the two successful applicants, Celltrion and Hospira, this development passes a significant milestone for the whole biosimilar sector as the products are the first monoclonal antibody (mAb) therapies to reach a positive opinion following review via the EMA biosimilars regulatory pathway. This is an important event which heralds a new era of lower-cost biological therapies in Europe.
For J&J and its partners, the news is less welcome. Already under pressure from branded competitors in the TNF inhibitor market, it is no surprise that both developer and biosimilar companies will be assessing what share they may secure of its US$6.13 billion revenues.

The tip of a US$41 billion iceberg

While significant for J&J, infliximab is just the tip of the iceberg when it comes to the potential for biosimilars. In terms of revenue, six of the top ten pharmaceutical therapies are biological products, which have been targeted by biosimilar developers: Abbvie’s Humira (adalimumab), Roche’s MabThera (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab), Sanofi’s Lantus (insulin glargine), and Johnson & Johnson’s Remicade (infliximab). These products had combined global sales of US$41.4 billion in 2012. Also
of significant importance to biosimilar developers, with sales of US$4.2 billion in 2012 is Amgen’s Enbrel (etanercept).

Open season: Branded industry gets in on the act

It may have taken a while, but the world’s major pharmaceutical originators have recognised the potential for biosimilars. A number have disclosed their intentions and/or announced clinical trials in recent months. For example, in February 2013, Amgen announced plans to launch a portfolio of six new biosimilars beginning in 2017: adalimumab, infliximab, bevacizumab, trastuzumab, rituximab and cetuximab. Four of these projects form part of the
company’s development agreement with Actavis. In June 2012, Merck KGaA and Dr Reddy's Laboratories announced a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies. Pfizer has been openly active in generics and biosimilars for some time. The company previously had a collaborative deal with Biocon for its insulin products, although this deal was concluded in March 2012. In May 2013, Pfizer began a Phase I trial with an infliximab biosimilar, PF-06438179. Many smaller biosimilar developers have the ambition but not the resources. The increasing interest from big Pharma will bring a welcome boost of expertise and funding to research and partnering.

The US Market: Not the elephant in the room

In any analysis of the pharma industry the US looms large – but not in biosimilars. The painfully slow progress to a regulatory pathway for biosimilars – still untried – has handed the initiative to others. The EU biosimilar regulations have been imitated widely in other countries, while the emphasis of biosimilar research sits firmly in Asia, notably India, China and South Korea. Of course, the big prize for all biosimilar manufacturers is the US market, which accounts for approximately 50% of the global value.

This report answers key questions:

Where is less competition to be found in the first phase of biosimilars in Epoetin and G-CSF?
Biosimilars are more widely available in emerging markets – what lessons can be learnt?
What are the latest State regulatory developments in the US and will they help or hinder?
Which are the companies to watch, and why?
Six companies are targeting Abbvie’s Humira, who are they and what is the status of their research?

Foreword & Executive Summary

• Biosimilars: What Are They and Why
Are We Interested?
• What Is A Biotech Drug?
• Biosimilars and Biobetters Defined
Product Analysis
Each product review which follows covers,
where appropriate,
• Developer/Background
• Mode of Action
• Approvals
• Competition within the Marketplace
• Patents
• Sales Trends
First Generation Biosimilars
Erythropoietin
• Epogen/Eprex/Procrit (epoetin alfa)
• Aranesp (darbepoetin alfa)
• NeoRecormon (epoetin beta)
• Mircera (methoxy polyethylene glycolepoetin
beta)
• Biosimilar Erythropoietin
?? Europe
?? USA
?? Rest of the World (Epoetin &
Darbepoetin)
G-CSF
• Neupogen (filgrastim)
• Neulasta (pegfilgrastim)
• Neutrogin/Granocyte (lenograstim)
• Biosimilar G-CSF
?? Europe (Filgrastim and
Pegfilgrastim)
?? USA
?? Rest of the World
Human Growth Hormone (Somatropin)
• Genotropin
• Humatrope
• Norditropin
• Nutropin
• Saizen
• Biosimilar Somatropin
?? Europe
?? USA
?? Rest of the World
Follicle Stimulating Hormone
• Gonal-f (follitropin alfa)
• Biosimilar Follitropin Alfa
?? Europe
?? USA
?? Rest of the World
Human Insulin
• Humulin (insulin [rDNA origin])
• Humalog (insulin lispro)
• Lantus (insulin glargine)
• Apidra (insulin glulisine)
• Levemir (insulin detemir)
• NovoRapid & NovoMix (insulin aspart)
• Biosimilar Human Insulin
?? Europe and USA
?? Rest of the World
Interferon
• PegIntron (peginterferon alfa-2b)
• Pegasys (pegylated-40K interferon
alfa-2a)
• Avonex (interferon beta-1a)
• Rebif (interferon beta-1a)
• Betaferon/Betaseron & Extavia
(interferon beta-1b)
• Biosimilar Interferon
?? Europe
?? Rest of the World
The Next Biosimilar Generation:
Etanercept and Monoclonal Antibodies
• Enbrel (etanercept)
• Biosimilar Etanercept
• Remicade (infliximab)
• Rituxan/MabThera (rituximab)
• Herceptin (trastuzumab)
• Humira (adalimumab)
• Avastin (bevacizumab)
• Erbitux (cetuximab)
Biosimilar mAb Development
• Adalimumab
• Bevacizumab
• Cetuximab
• Infliximab
• Rituximab
• Trastuzumab
• Multiple mAb Development
Agreements
?? Oncobiologics Biosimilar
Collaborations
Biosimilar Regulation
• European Union
• United States
Regulation in Other Developed Markets
• Australia
• Canada
• Japan
• Singapore
Regulation in Emerging Markets
• Brazil
• India
• Malaysia
• Mexico
• Peru
• South Korea
• Turkey
The Key Players
• Sandoz
• Teva
• Hospira
Companies to Watch
• Actavis
• Biocon and Mylan
• Celltrion
• Ranbaxy
Major Pharma Companies – Recent
Developments
• Amgen
• Merck & Co and Samsung Bioepis
• Merck Serono and Dr Reddy’s
• Pfizer
• Sanofi
Company Directory List of Tables
• Biosimilars Approved in the EU
• Five-year Sales of Leading EPO Brands (US$ M)
• Epogen US Patents
• Epogen/Eprex/Procrit Sales, 2003-2012 (US$ M)
• Aranesp US & EU Patents
• Aranesp Sales, 2003-2012 (US$ M)
• NeoRecormon/Epogin Sales, 2003-2012 (CHF & US$ M)
• Mircera Sales, 2003-2012 (CHF & US$ M)
• EU Marketing Authorisations for Biosimilar Eprex
• Biosimilar Epoetin in Emerging Markets
• Five-year Sales of Leading G-CSF Brands (US$ M)
• Filgrastim US Patents
• Neupogen Sales, 2003-2012 (US$ M)
• Pegfilgrastim Patents
• Neulasta Sales, 2003-2012 (US$ M)
• Neutrogin/Granocyte Sales, 2003-2012 (CHF & US$ M)
• EU Marketing Authorisations for Biosimilar Filgrastim
• Biosimilar G-CSF in Emerging Markets
• Five-year Sales of Leading Somatropin Brands (US$ M)
• Gentropin Sales, 2003-2012 (US$ M)
• Humatrope Sales, 2003-2012 (US$ M)
• Norditropin Sales, 2003-2012 (DKK & US$ M)
• Nutropin Sales, 2003-2012 (US$ M)
• Saizen Sales, 2003-2012 (EUR & US$ M)
• Biosimilar HGH in Emerging Markets
• Gonal-f US Patents
• Gonal-f Sales, 2003-2012 (EUR & US$ M)
• Biosimilar FSH in Emerging Markets
• Five-Year Sales of Leading Insulin Brands (US$ M)
• Humulin Sales, 2003-2012 (US$ M)
• Humalog US Patents
• Humalog Sales, 2003-2012 (US$ M)
• Lantus US Patents
• Lantus Sales, 2003-2012 (EUR & US$ M)
• Apidra US Patents
• Apidra Sales, 2008-2012 (EUR & US$ M)
• Levemir US Patents
• Levemir Sales, 2005-2012 (DKK & US$ M)
• NovoRapid & NovoMix US Patents
• NovoRapid & NovoMix Sales, 2005-2012 (DKK & US$ M)
• Five-year Sales of Leading Interferon Alfa Brands (US$ M)
• Five-year Sales of Leading Interferon Beta Brands (US$ M)
• PegIntron US Patents
• PegIntron Sales, 2003-2012 (US$ M)
• Pegasys US Patents
• Pegasys Sales, 2003-2012 (CHF & US$ M)
• Avonex US Patents
• Avonex Sales 2003-2012 (US$ M)
• Rebif Sales, 2003-2012 (EUR & US$ M)
• Betaferon/Betaseron & Extavia Sales, 2003-2012
(EUR & US$ M)
• Biosimilar Interferon in Emerging Markets
• Five-Year Sales of Enbrel and Leading Monoclonal
Antibodies (US$ M)
• Enbrel US Patents
• Enbrel Sales by Company, 2003-2012 (US$ M)
• Remicade US Patents
• Remicade Sales by Company, 2003-2012 (US$ M)
• Rituxan/MabThera Sales, 2003-2012 (CHF & US$ M)
• Herceptin US Patents
• Herceptin Sales, 2003-2012 (CHF & US$)
• Humira US Patents
• Humira Sales by Company, 2003-2012 (US$ M)
• Avastin Sales, 2004-2012 (CHF & US$ M)
• Erbitux Sales by Company, 2004-2012 (EUR & US$ M)

Table Of Contents

Foreword 1

Executive Summary 3

Biosimilars: What Are They And Why Are We Interested? 5

What Is A Biotech Drug? 5
Biosimilars And Biobetters Defined 6

First Generation Biosimilars 7

Erythropoietin 8
Epogen/Eprex/Procrit (epoetin alfa) 10
Mode of Action 10
Approvals 10
Competition within the Marketplace 10
Patents 10
Sales Trends 11
Aranesp (darbepoetin alfa) 12
Mode of Action 12
Approvals 12
Competition within the Marketplace 12
Patents 13
Sales Trends 13
NeoRecormon (epoetin beta) 15
Mode of Action 15
Approvals 15
Competition within the Marketplace 15
Sales Trends 15
Mircera (methoxy polyethylene glycol-epoetin beta) 17
Mode of Action 17
Approvals 17
Competition within the Marketplace 17
Sales Trends 17
Biosimilar Erythropoietin 19
Europe 19
USA 20
Rest of the World 20
Epoetin 20
Darbepoetin 21
G-CSF 22
Neupogen (filgrastim) 24
Mode of Action 24
Approvals 24
Competition within the Marketplace 24
Patents 24
Sales Trends 25
Neulasta (pegfilgrastim) 26
Mode of Action 26
Approvals 26
Competition within the Marketplace 26
Patents 27
Sales Trends 27
Neutrogin/Granocyte (lenograstim) 28
Mode of Action 28
Approvals 28
Competition within the Marketplace 28
Sales Trends 28
Biosimilar G-CSF 30
Europe 30
Filgrastim 30
Pegfilgrastim 31
USA 31
Rest of the World 31
Hormones 33
Human Growth Hormone (Somatropin) 33
Genotropin 35
Humatrope 36
Norditropin 37
Nutropin 38
Saizen 39
Biosimilar Somatropin 40
Europe 40
USA 40
Rest of the World 40
Follicle Stimulating Hormone 42
Gonal-f (follitropin alfa) 42
Mode of Action 42
Approvals 42
Patents 42
Sales Trends 43
Biosimilar Follitropin Alfa 44
Europe 44
USA 44
Rest of the World 44
Human Insulin 45
Humulin (insulin [rDNA origin]) 47
Mode of Action 47
Approvals 47
Competition within the Marketplace 47
Sales Trends 47
Humalog (insulin lispro) 49
Mode of Action 49
Approvals 49
Competition within the Marketplace 49
Patents 49
Sales Trends 50
Lantus (insulin glargine) 51
Mode of Action 51
Approvals 51
Competition within the Marketplace 51
Patents 51
Sales Trends 52
Apidra (insulin glulisine) 53
Mode of Action 53
Approvals 53
Competition within the Marketplace 53
Patents 53
Sales Trends 54
Levemir (insulin detemir) 55
Mode of Action 55
Approvals 55
Competition within the Marketplace 55
Patents 55
Sales Trends 56
NovoRapid and NovoMix (insulin aspart) 57
Mode of Action 57
Approvals 57
Competition within the Marketplace 57
Patents 57
Sales Trends 58
Biosimilar Human Insulin 59
Europe and USA 59
Rest of the World 60
Interferon 61
PegIntron (peginterferon alfa-2b) 62
Mode of Action 62
Approvals 62
Competition within the Marketplace 62
Patents 62
Sales Trends 63
Pegasys (pegylated-40K interferon alfa-2a) 64
Mode of Action 64
Approvals 64
Competition within the Marketplace 64
Patents 64
Sales Trends 65
Avonex (interferon beta-1a) 66
Mode of Action 66
Approvals 66
Competition within the Marketplace 66
Patents 67
Sales Trends 67
Rebif (interferon beta-1a) 68
Mode of Action 68
Approvals 68
Competition within the Marketplace 68
Sales Trends 68
Betaferon/Betaseron and Extavia (interferon beta-1b) 70
Mode of Action 70
Approvals 70
Competition within the Marketplace 70
Patents 70
Sales Trends 70
Biosimilar Interferon 72
Europe 72
Rest of the World 72
The Next Biosimilar Generation: Etanercept and Monoclonal Antibodies 74
Enbrel (etanercept) 76
Mode of Action 76
Approvals 76
Competition within the Marketplace 76
Patents 76
Sales Trends 77
Biosimilar Etanercept 78
Remicade (infliximab) 80
Mode of Action 80
Approvals 80
Competition within the Marketplace 80
Patents 80
Sales Trends 81
Rituxan/MabThera (rituximab) 83
Mode of Action 83
Approvals 83
Competition within the Marketplace 83
Patents 84
Sales Trends 84
Herceptin (trastuzumab) 85
Mode of Action 85
Approvals 85
Competition within the Marketplace 85
Breast Cancer 85
Gastric Cancer .86
Patents 86
Sales Trends 86
Humira (adalimumab) 88
Mode of Action 88
Approvals 88
Competition within the Marketplace 88
Patents 88
Sales Trends 89
Avastin (bevacizumab) 90
Mode of Action 90
Approvals 90
Competition within the Marketplace 91
Patents 91
Sales Trends 91
Erbitux (cetuximab) 93
Mode of Action 93
Approvals 93
Competition within the Marketplace 93
Patents 94
Sales Trends 94
Biosimilar mAb Development 96
Adalimumab 96
Bevacizumab 96
Cetuximab 96
Infliximab 97
Rituximab 97
Trastuzumab 98
Multiple mAb Development Agreements 98
Oncobiologics Biosimilar Collaborations 98

Biosimilar Regulation 100

European Union 100
United States 101
Legislation Progress in the United States 102
Virginia Passes Biosimilar Legislation 102
Mississippi Rejects Legislation 103
Regulation in Other Developed Markets 103
Australia 103
Canada 103
Japan 103
Singapore 104
Regulation in Emerging Markets 104
Brazil 104
India 104
Malaysia 105
Mexico 105
Peru 105
South Korea 105
Turkey 106

The Key Players 107

Sandoz 107
Teva 107
Hospira 108
Companies to Watch 109
Actavis 109
Biocon and Mylan 109
Celltrion 110
Ranbaxy 110
Major Pharma Companies - Recent Developments 111
Amgen 111
Merck and Co and Samsung Bioepis 111
Merck Serono and Dr Reddy’s 111
Pfizer 112
Sanofi 112

Company Directory 113

List of Tables

Biosimilars Approved in the EU 7
Five-year Sales of Leading EPO Brands (US$ Million) 8
Epogen US Patents 10
Epogen/Eprex/Procrit Sales, 2003-2012 (US$ Million) 11
Aranesp US and EU Patents 13
Aranesp Sales, 2003-2012 (US$ Million) 13
NeoRecormon/Epogin Sales, 2003-2012 (CHF and US$ Million) 16
Mircera Sales, 2003-2012 (CHF and US$ Million) 18
EU Marketing Authorisations for Biosimilar Eprex 19
Biosimilar Epoetin in Emerging Markets 21
Five-year Sales of Leading G-CSF Brands (US$ Million) 22
Filgrastim US Patents 25
Neupogen Sales, 2003-2012 (US$ Million) 25
Pegfilgrastim Patents 27
Neulasta Sales, 2003-2012 (US$ Million) 27
Neutrogin/Granocyte Sales, 2003-2012 (CHF and US$ Million) 28
EU Marketing Authorisations for Biosimilar Filgrastim 30
Biosimilar G-CSF in Emerging Markets 32
Five-year Sales of Leading Somatropin Brands (US$ Million) 33
Gentropin Sales, 2003-2012 (US$ Million) 35
Humatrope Sales, 2003-2012 (US$ Million) 36
Norditropin Sales, 2003-2012 (DKK and US$ Million) 37
Nutropin Sales, 2003-2012 (US$ Million) 38
Saizen Sales, 2003-2012 (EUR and US$ Million) 39
Biosimilar HGH in Emerging Markets 41
Gonal-f US Patents 42
Gonal-f Sales, 2003-2012 (EUR and US$ Million) 43
Biosimilar FSH in Emerging Markets 44
Five-Year Sales of Leading Insulin Brands (US$ Million) 45
Humulin Sales, 2003-2012 (US$ Million) 47
Humalog US Patents 49
Humalog Sales, 2003-2012 (US$ Million) 50
Lantus US Patents 51
Lantus Sales, 2003-2012 (EUR and US$ Million) 52
Apidra US Patents 53
Apidra Sales, 2008-2012 (EUR and US$ Million) 54
Levemir US Patents 55
Levemir Sales, 2005-2012 (DKK and US$ Million) 56
NovoRapid and NovoMix US Patents 58
NovoRapid and NovoMix Sales, 2005-2012 (DKK and US$ Million) 58
Five-year Sales of Leading Interferon Alfa Brands (US$ Million) 61
Five-year Sales of Leading Interferon Beta Brands (US$ Million) 61
PegIntron US Patents 62
PegIntron Sales, 2003-2012 (US$ Million) 63
Pegasys US Patent 65
Pegasys Sales, 2003-2012 (CHF and US$ Million) 65
Avonex US Patents 67
Avonex Sales 2003-2012 (US$ Million) 67
Rebif Sales, 2003-2012 (EUR and US$ Million) 69
Betaferon/Betaseron and Extavia Sales, 2003-2012 (EUR and US$ Million) 71
Biosimilar Interferon in Emerging Markets 72
Five-Year Sales of Enbrel and Leading Monoclonal Antibodies (US$ Million) 74
Enbrel US Patents 77
Enbrel Sales by Company, 2003-2012 (US$ Million) 77
Remicade US Patents 80
Remicade Sales by Company, 2003-2012 (US$ Million) 81
Rituxan/MabThera Sales, 2003-2012 (CHF and US$ Million) 84
Herceptin US Patents 86
Herceptin Sales, 2003-2012 (CHF and US$ Million) 86
Humira US Patents 88
Humira Sales by Company, 2003-2012 (US$ Million) 89
Avastin Sales, 2004-2012 (CHF and US$ Million) 91
Erbitux Sales by Company, 2004-2012 (EUR and US$ Million) 94

List of Figures

Leading EPO Brands, Global Sales 2003-2012 (%) 9
Leading EPO Brands, Revenue Share 2012 (%) 9
Epogen/Eprex/Procrit Sales, 2003-2012 (US$ Million) 11
Aranesp Sales, 2003-2012 (US$ Million) 14
NeoRecormon/Epogin Sales, 2003-2012 (US$ Million) 16
Mircera Sales, 2003-2012 (US$ Million) 18
Leading G-CSF Brands, Global Sales 2003-2012 (%) 22
Leading G-CSF Brands, Revenue Share 2012 (%) 23
Neupogen Sales, 2003-2012 (US$ Million) 25
Neulasta Sales, 2003-2012 (US$ Million) 27
Neutrogin/Granocyte Sales, 2003-2012 (US$ Million) 29
Leading Somatropin Brands, Global Sales 2003-2012 (US$ Million) 33
Leading Somatropin Brands, Revenue Share 2012 (%) 34
Gentropin Sales, 2003-2012 (US$ Million) 35
Humatrope Sales, 2003-2012 (US$ Million) 36
Norditropin Sales, 2003-2012 (US$ Million) 37
Nutropin Sales, 2003-2012 (US$ Million) 38
Saizen Sales, 2003-2012 (US$ Million) 39
Gonal-f Sales, 2003-2012 (US$ Million) 43
Leading Insulin Brands, Global Sales 2005-2012 (US$ Million) 46
Humulin Sales, 2003-2012 (US$ Million) 48
Humalog Sales, 2003-2012 (US$ Million) 50
Lantus Sales, 2003-2012 (US$ Million) 52
Apidra Sales, 2008-2012 (US$ Million) 54
Levemir Sales, 2005-2012 (US$ Million) 56
NovoRapid and NovoMix Sales, 2005-2012 (US$ Million) 58
PegIntron Sales, 2003-2012 (US$ Million) 63
Pegasys Sales, 2003-2012 (US$ Million) 65
Avonex Sales, 2003-2012 (US$ Million) 67
Rebif Sales, 2003-2012 (US$ Million) 69
Betaferon/Betaseron and Extavia Sales, 2003-2012 (US$ Million) 71
Enbrel Sales, 2003-2012 (US$ Million) 78
Remicade Sales, 2003-2012 (US$ Million) 82
Rituxan/MabThera Sales, 2003-2012 (US$ Million) 84
Herceptin Sales, 2003-2012 (US$ Million) 87
Humira Sales, 2003-2012 (US$ Million) 89
Avastin Sales, 2004-2012 (US$ Million) 92
Erbitux Sales, 2004-2012 (US$ Million) 95

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