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Biosimilar Opportunities in an Evolving Market

December 10, 2013

Reportbuyer.com just published a new market research report: Biosimilar Opportunities in an Evolving Market.

London (PRWEB) December 10, 2013

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)

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 & 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 & 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 & 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 & EU Patents 13

Aranesp Sales, 2003-2012 (US$ Million) 13

NeoRecormon/Epogin Sales, 2003-2012 (CHF & US$ Million) 16

Mircera Sales, 2003-2012 (CHF & 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 & 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 & US$ Million) 37

Nutropin Sales, 2003-2012 (US$ Million) 38

Saizen Sales, 2003-2012 (EUR & US$ Million) 39

Biosimilar HGH in Emerging Markets 41

Gonal-f US Patents 42

Gonal-f Sales, 2003-2012 (EUR & 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 & US$ Million) 52

Apidra US Patents 53

Apidra Sales, 2008-2012 (EUR & US$ Million) 54

Levemir US Patents 55

Levemir Sales, 2005-2012 (DKK & US$ Million) 56

NovoRapid & NovoMix US Patents 58

NovoRapid & NovoMix Sales, 2005-2012 (DKK & 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 & US$ Million) 65

Avonex US Patents 67

Avonex Sales 2003-2012 (US$ Million) 67

Rebif Sales, 2003-2012 (EUR & US$ Million) 69

Betaferon/Betaseron & Extavia Sales, 2003-2012 (EUR & 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 & US$ Million) 84

Herceptin US Patents 86

Herceptin Sales, 2003-2012 (CHF & US$ Million) 86

Humira US Patents 88

Humira Sales by Company, 2003-2012 (US$ Million) 89

Avastin Sales, 2004-2012 (CHF & US$ Million) 91

Erbitux Sales by Company, 2004-2012 (EUR & 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 & 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 & 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

Read the full report:

Biosimilar Opportunities in an Evolving Market

http://www.reportbuyer.com/countries/north_america/usa/biosimilar_opportunities_evolving_market.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

For more information:

Sarah Smith

Research Advisor at Reportbuyer.com

Email: query@reportbuyer.com

Tel: +44 208 816 85 48

Website: http://www.reportbuyer.com

For the original version on PRWeb visit: http://www.prweb.com/releases/2013/12/prweb11408834.htm


Source: prweb



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