Global Biosimilars: Identifying 2nd Generation Opportunities


January 17, 2011
194 Pages - SKU: ESPI6067531
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Foreword
Executive Summary
What is a biologic drug?
What’s in a name?
Why are Biosimilars an issue?
products in the ‘first wave’
Erythropoietin (Epoetin, EPO)
What is it?
Who makes it?
Summary sales data
Company-specific sales data
Procrit/Eprex
Epogen/Aranesp
Neorecormon/Epogin
Current biosimilar activity
USA
Europe
Rest of the world
Human Growth Hormone (somatropin)
What is it?
Who makes it?
Summary sales data
Company specific sales data
Genotropin
Humatrope
Norditropin/other Novo Nordisk HGH products
Nutropin
Saizen/Serostim
Bio-Tropin
Current biosimilar activity
USA
European Union
Rest of the world
G-CSF
What is it?
Who makes it?
Summary sales data
Company specific sales data
Neupogen/Neulasta
Neutrogin/Granocyte
Leukine
Current Biosimilar Activity
USA
European Union
Current biosimilar activity in the rest of the world
Human Insulin
What is it?
Who makes it?
Summary sales data
Company specific sales data
Novo Nordisk recombinant insulin products
sanofi-aventis recombinant insulin products: Lantus, Apidra
Current biosimilar activity
USA
European Union
Rest of the World
Interferon
What is it?
Who makes it?
Summary sales data
Company specific sales data
Schering-Plough Interferon A (Intron A range)
Betaseron/Betaferon
Rebif
Current Biosimilar Activity
USA
European Union
Rest of the World
Beyond the First wave
Etanercept
Summary sales data - Amgen (USA & Canada)
Summary sales data - Pfizer (Outside USA & Canada)
Current Biosimilar activity
Monoclonal Antibodies
Adalimumab
Summary sales data
Current Biosimilar activity
Bevacizumab
Summary sales data
Current Biosimilar activity
Cetuximab
Summary sales data
Current Biosimilar activity
Infliximab
Summary sales data
Current Biosimilar activity
Rituximab
Summary sales data
Current Biosimilar activity
Dr Reddy’s: Reditux
Trastuzumab
Summary sales data
Current Biosimilar activity
Why are biosimilars an issue now?
Rising cost of healthcare
Is there a commercially viable market?
The price reduction of the biosimilar
Case Study: Biosimilar prices in the UK
Omnitrope
G-CSF
EPO
Patient population
Physician & patient acceptance
Attitudes to Biosimilars: UK Parliamentary Panel Reports
MHRA issues biosimilar prescribing guidance
Potential use of biosimilars in the NHS
Panel recommendations
HGH prescribing levels in England, 2009
Regulatory attitude
National pricing & reimbursement policies
Interchangeability and substitutability
Norway makes biosimilar G-CSF switchable - then changes its mind
Extent of existing competition
US surveys into cost savings
PCMA
Express Scripts
Avalere report
Insmed releases report on cost savings
CBO issues report on impact of biosimilars
Counter-arguments from BIO
President’s budget proposal, 2010
Originator strategies to counter biosimilars
Global market size estimates, 2015
The Regulatory Situation in the USA
Overview of the US regulatory system
Hatch-Waxman is not generally applicable to biologics
The 505(b)(2) route
Enoxaparin
Another option: file a full BLA?
The Development of a US Biosimilar Pathway
The BCPIA
Approval will be no guarantee of interchangeability
Biosimilar market exclusivity
Reference product data exclusivity
Patent dispute resolution
User fees
Implementation of the BCPIA
The Regulatory Situation in Europe
Regulation of biosimilars
EMA Guideline Documents
Regulation of Monoclonal Antibodies
Regulations in Other Developed Markets
Australia
Canada
Japan
Singapore
Regulations in Developing markets
Why are these markets worth a look?
India
Indonesia
Mexico
Saudi Arabia
Thailand
Who will be the players in the market?
Current Market Leaders
Sandoz
Omnitrope
Binocrit
Zarzio
Agreements
Sandoz’ Biosimilar Sales
Teva Pharmaceutical Industries
Tevagrastim/Neutroval
Rituximab
Teva’s Biosimilar Sales
Hospira
Retacrit
Nivestim
Distribution deal with Celltrion
Pliva sells biosimilar rights and facility to Hospira
The Indian Biosimilar Industry
Avesthagen
AVDESP
Avent
BiotechCorp
Siegfried Biologics
Intas Pharmaceuticals
Biocon
Basalog
Insugen
Erypro
NUFIL
Other products
Pfizer and Biocon announce major insulin deal
Biocon takes 100% control of JV from CIMAB
Mylan and Biocon announce biosimilar deal
Biocon buys majority stake in German marketing company
Cipla
Mab Pharma/Bio Mabs
Claris Lifesciences
Dr Reddy‘s
Gennova Biopharmaceuticals
Intas Biopharmaceuticals
New mAb facility announced
Intas and Apotex sign G-CSF agreement
MJ Biopharma
Reliance Life Sciences
Shantha Biotechnics
Wockhardt
Zenotech Laboratories
Other Developers: Europe
Actavis
BioPartners
Bioton
Selexis
Stada Arzneimittel
EPO-zeta gains EU approval
Other Developers: Asia, Africa, Middle East
3SBio
Bioclones
Celltrion
Hikma and Celltrion enter biosimilars agreement for the MENA region
Egis to distribute Celltrion products
Cinnagen
CJ Corp
Getz Pharma
Inno Biologics
LG Life Sciences
Mycenax Biotech
Protalix
Samsung
SciGen
Simcere/Shanghai Celgen
Other Developers: Americas
Biolex Therapeutics
Cangene
Cell Therapeutics
CIGB
Elona Biotechnologies
GTC Biotherapeutics
Itero Biopharmaceuticals
Momenta Pharmaceuticals
Mylan
Marketing Deal with Biocon
Three Rivers Pharmaceuticals
Viropro
Watson
Itero and Watson announce rFSH agreement
‘Big Pharma’ Companies
Merck & Co
Former Insmed G-CSF products
Merck discontinues EPO project
Pfizer
Insulin deal with Biocon
Sources
Directory
Regulators
Industry Associations
Manufacturers
Index
INDEX OF TABLES
Leading EPO Brands, World Sales, 2001-2009 (US$ millions)
Leading EPO Brands, % Change in Sales, 2002-09
Leading EPO Brands, % of Subtotal, 2001-2009
J&J Sales of Procrit/Eprex, 2001-2009 (US$ millions)
Amgen Sales of Epogen/Aranesp, 2001-2009 (US$ millions)
Amgen EPO Patents in the USA
Roche Sales of Neorecormon/Epogin, 2002-2009 (SwF millions)
Biosimilar EPO: manufacturers' summary
Leading HGH Brands, World Sales, 2001-2009 (US$ millions)
Leading HGH Brands, % Change (US$ sales), 2002-09
Leading HGH Brands, % of Subtotal, 2001-2009
Genotropin Sales, 2001-09 (US$ millions)
Humatrope Sales, 2001-09 (US$ millions)
Novo Nordisk HGH Sales, 2001-09 (DKK millions)
Roche/Genentech HGH Sales, 2001-09 (US$ millions)
Merck/Serono HGH Sales, 2001-2009 (US$ millions)
Biosimilar HGH: Manufacturers' Summary
Leading G-CSF Brands, World Sales, 2001-2009 (US$ millions)
Leading G-CSF Brands, % Change 2003-09
Leading G-CSF Brands, % of Total, 2002-09
Neupogen/Neulasta Sales, 2001-09 (US$ billions)
Sales of Neutrogin/Granocyte, 2002-09 (billion yen)
Biosimilar G-CSF: Manufacturers' Summary
Leading Human Insulin brands, World Sales, 2001-2009 (US$ millions)
Leading Human Insulin Brands, % Change, 2002-2009
Leading Human Insulin Brands, % of Subtotal, 2001-2009
Sales of Novo Nordisk Insulin Analogues, 2001-2009 (DKK million)
Sales of Humulin and Humalog, 2001-2009 (US$000s)
Lantus Sales by Region, 2004-09 (euro millions)
Biosimilar Human Insulin: Manufacturers' Summary
Leading Interferon Brands, World Sales, 2001-2009 (US$ millions)
Leading Interferon Brands, % of Subtotal, 2002-2009
Sales of Intron A and PEG-Intron, 2002-2009 (US$ millions)
Sales of Pegasys, 2002-09 (SwF millions)
Sales of Betaseron/Betaferon, 2001-09 (euro millions)
Sales of Avonex, 2001-09 (US$ millions)
Sales of Rebif, 2001-09 (US$ millions)
Biosimilar Interferons: Manufacturers' Summary
Summary, factors in favour of the development of biosimilars
UK NHS Price Comparison, Omnitrope v other HGH Brands, 2008-10
UK NHS Price Comparison, Ratiograstim v Neupogen, 2009-10
UK NHS Price Comparison, EPO 2009
UK NHS Price Comparison, EPO 2010
Anticipated Annual Savings to the Healthcare Budget from the Introduction
of a Biosimilar Pathway, 2013-19 (US$ millions)
Estimated Global Biosimilar Market Size (EPO, G-CSF and HGH), 2015 (US$ millions)
CHMP General Biosimilar Guidelines
Other Relevant General Guidelines
CHMP Product-Specific Guidelines
Summary Requirements, Chemical Generic v Biosimilars
Summary of Biosimilar Manufacturers and Products
2009 US$ exchange rates used in this report
 
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