Product Code: 978-1-909584-30-3
Abstract
The long awaited promise of biosimilars takes another step to fulfilment with
the first approval in Europe of high-value second generation products. But
what products can be expected to follow, who is developing them and what are
the hot prospects?
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
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
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)
About the Author
The report has been researched and written by experienced independent market
analyst, Karen Holmes. Karen has over 17 years pharmaceutical and healthcare
market analysis experience. Among her many reports for Espicom are:
- Hospital Generic Drugs: Prospects for Generics and Biosimilars
- The Indian Pharmaceutical Industry: Expansion & Ambitions
- Understanding Brazil's Regional Health Markets
- The Complete Guide to Companion Diagnostics
About the Publisher
Espicom Business Intelligence is a leading provider of specialist
pharmaceutical market information. Based in the UK and with over 30 years of
experience, the company produces a broad range of business and therapy titles,
with a particular emphasis on the global generics market, and is uniquely
placed to publish this report. Espicom is part of Business Monitor
International.
Table of Contents
Foreword
Executive Summary
Biosimilars: What Are They And Why Are We Interested?
- What Is A Biotech Drug?
- Biosimilars And Biobetters Defined
First Generation Biosimilars
- Erythropoietin
- Epogen/Eprex/Procrit (epoetin alfa)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Aranesp (darbepoetin alfa)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- NeoRecormon (epoetin beta)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Sales Trends
- Mircera (methoxy polyethylene glycol-epoetin beta)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Sales Trends
- Biosimilar Erythropoietin
- Europe
- USA
- Rest of the World
- G-CSF
- Neupogen (filgrastim)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Neulasta (pegfilgrastim)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Neutrogin/Granocyte (lenograstim)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Sales Trends
- Biosimilar G-CSF
- Europe
- USA
- Rest of the World
- Hormones
- Human Growth Hormone (Somatropin)
- Genotropin
- Humatrope
- Norditropin
- Nutropin
- Saizen
- Biosimilar Somatropin
- Europe
- USA
- Rest of the World
- Follicle Stimulating Hormone
- Gonal-f (follitropin alfa)
- Mode of Action
- Approvals
- Patents
- Sales Trends
- Biosimilar Follitropin Alfa
- Europe
- USA
- Rest of the World
- Human Insulin
- Humulin (insulin [rDNA origin])
- Mode of Action
- Approvals
- Competition within the Marketplace
- Sales Trends
- Humalog (insulin lispro)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Lantus (insulin glargine)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Apidra (insulin glulisine)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Levemir (insulin detemir)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- NovoRapid & NovoMix (insulin aspart)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Biosimilar Human Insulin
- Europe and USA
- Rest of the World
- Interferon
- PegIntron (peginterferon alfa-2b)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Pegasys (pegylated-40K interferon alfa-2a)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Avonex (interferon beta-1a)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Rebif (interferon beta-1a)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Sales Trends
- Betaferon/Betaseron & Extavia (interferon beta-1b)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Biosimilar Interferon
- The Next Biosimilar Generation: Etanercept and Monoclonal Antibodies
- Enbrel (etanercept)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Biosimilar Etanercept
- Remicade (infliximab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Rituxan/MabThera (rituximab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Herceptin (trastuzumab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Breast Cancer
- Gastric Cancer
- Patents
- Sales Trends
- Humira (adalimumab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Avastin (bevacizumab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Erbitux (cetuximab)
- Mode of Action
- Approvals
- Competition within the Marketplace
- Patents
- Sales Trends
- Biosimilar mAb Development
- Adalimumab
- Bevacizumab
- Cetuximab
- Infliximab
- Rituximab
- Trastuzumab
- Multiple mAb Development Agreements
- Oncobiologics Biosimilar Collaborations
Biosimilar Regulation
- European Union
- United States
- Legislation Progress in the United States
- Virginia Passes Biosimilar Legislation
- Mississippi Rejects Legislation
- 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$ Million)
- Epogen US Patents
- Epogen/Eprex/Procrit Sales, 2003-2012 (US$ Million)
- Aranesp US & EU Patents
- Aranesp Sales, 2003-2012 (US$ Million)
- NeoRecormon/Epogin Sales, 2003-2012 (CHF & US$ Million)
- Mircera Sales, 2003-2012 (CHF & US$ Million)
- EU Marketing Authorisations for Biosimilar Eprex
- Biosimilar Epoetin in Emerging Markets
- Five-year Sales of Leading G-CSF Brands (US$ Million)
- Filgrastim US Patents
- Neupogen Sales, 2003-2012 (US$ Million)
- Pegfilgrastim Patents
- Neulasta Sales, 2003-2012 (US$ Million)
- Neutrogin/Granocyte Sales, 2003-2012 (CHF & US$ Million)
- EU Marketing Authorisations for Biosimilar Filgrastim
- Biosimilar G-CSF in Emerging Markets
- Five-year Sales of Leading Somatropin Brands (US$ Million)
- Gentropin Sales, 2003-2012 (US$ Million)
- Humatrope Sales, 2003-2012 (US$ Million)
- Norditropin Sales, 2003-2012 (DKK & US$ Million)
- Nutropin Sales, 2003-2012 (US$ Million)
- Saizen Sales, 2003-2012 (EUR & US$ Million)
- Biosimilar HGH in Emerging Markets
- Gonal-f US Patents
- Gonal-f Sales, 2003-2012 (EUR & US$ Million)
- Biosimilar FSH in Emerging Markets
- Five-Year Sales of Leading Insulin Brands (US$ Million)
- Humulin Sales, 2003-2012 (US$ Million)
- Humalog US Patents
- Humalog Sales, 2003-2012 (US$ Million)
- Lantus US Patents
- Lantus Sales, 2003-2012 (EUR & US$ Million)
- Apidra US Patents
- Apidra Sales, 2008-2012 (EUR & US$ Million)
- Levemir US Patents
- Levemir Sales, 2005-2012 (DKK & US$ Million)
- NovoRapid & NovoMix US Patents
- NovoRapid & NovoMix Sales, 2005-2012 (DKK & US$ Million)
- Five-year Sales of Leading Interferon Alfa Brands (US$ Million)
- Five-year Sales of Leading Interferon Beta Brands (US$ Million)
- PegIntron US Patents
- PegIntron Sales, 2003-2012 (US$ Million)
- Pegasys US Patent
- Pegasys Sales, 2003-2012 (CHF & US$ Million)
- Avonex US Patents
- Avonex Sales 2003-2012 (US$ Million)
- Rebif Sales, 2003-2012 (EUR & US$ Million)
- Betaferon/Betaseron & Extavia Sales, 2003-2012 (EUR & US$ Million)
- Biosimilar Interferon in Emerging Markets
- Five-Year Sales of Enbrel and Leading Monoclonal Antibodies (US$ Million)
- Enbrel US Patents
- Enbrel Sales by Company, 2003-2012 (US$ Million)
- Remicade US Patents
- Remicade Sales by Company, 2003-2012 (US$ Million)
- Rituxan/MabThera Sales, 2003-2012 (CHF & US$ Million)
- Herceptin US Patents
- Herceptin Sales, 2003-2012 (CHF & US$ Million)
- Humira US Patents
- Humira Sales by Company, 2003-2012 (US$ Million)
- Avastin Sales, 2004-2012 (CHF & US$ Million)
- Erbitux Sales by Company, 2004-2012 (EUR & US$ Million)
List of Figures
- Leading EPO Brands, Global Sales 2003-2012 (%)
- Leading EPO Brands, Revenue Share 2012 (%)
- Epogen/Eprex/Procrit Sales, 2003-2012 (US$ Million)
- Aranesp Sales, 2003-2012 (US$ Million)
- NeoRecormon/Epogin Sales, 2003-2012 (US$ Million)
- Mircera Sales, 2003-2012 (US$ Million)
- Leading G-CSF Brands, Global Sales 2003-2012 (%)
- Leading G-CSF Brands, Revenue Share 2012 (%)
- Neupogen Sales, 2003-2012 (US$ Million)
- Neulasta Sales, 2003-2012 (US$ Million)
- Neutrogin/Granocyte Sales, 2003-2012 (US$ Million)
- Leading Somatropin Brands, Global Sales 2003-2012 (US$ Million)
- Leading Somatropin Brands, Revenue Share 2012 (%)
- Gentropin Sales, 2003-2012 (US$ Million)
- Humatrope Sales, 2003-2012 (US$ Million)
- Norditropin Sales, 2003-2012 (US$ Million)
- Nutropin Sales, 2003-2012 (US$ Million)
- Saizen Sales, 2003-2012 (US$ Million)
- Gonal-f Sales, 2003-2012 (US$ Million)
- Leading Insulin Brands, Global Sales 2005-2012 (US$ Million)
- Humulin Sales, 2003-2012 (US$ Million)
- Humalog Sales, 2003-2012 (US$ Million)
- Lantus Sales, 2003-2012 (US$ Million)
- Apidra Sales, 2008-2012 (US$ Million)
- Levemir Sales, 2005-2012 (US$ Million)
- NovoRapid & NovoMix Sales, 2005-2012 (US$ Million)
- PegIntron Sales, 2003-2012 (US$ Million)
- Pegasys Sales, 2003-2012 (US$ Million)
- Avonex Sales, 2003-2012 (US$ Million)
- Rebif Sales, 2003-2012 (US$ Million)
- Betaferon/Betaseron & Extavia Sales, 2003-2012 (US$ Million)
- Enbrel Sales, 2003-2012 (US$ Million)
- Remicade Sales, 2003-2012 (US$ Million)
- Rituxan/MabThera Sales, 2003-2012 (US$ Million)
- Herceptin Sales, 2003-2012 (US$ Million)
- Humira Sales, 2003-2012 (US$ Million)
- Avastin Sales, 2004-2012 (US$ Million)
- Erbitux Sales, 2004-2012 (US$ Million)
