|
Published by: Espicom Healthcare Intelligence
Published: Oct. 15, 2009 - 218 Pages
Table of Contents
- 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?
- Developments on the Horizon
- Mircera
- EU Approval for Mircera
- Dynepo
- Summary sales data
- Company-specific sales data
- Procrit/Eprex
- Epogen/Aranesp
- Neorecormon/Epogin
- Current biosimilar activity
- Current biosimilar activity in the USA
- Current biosimilar activity in the EU
- Sandoz
- Hospira/Stada Arzneimittel
- EPO zeta trial data published
- Others in Europe
- EMEA proposes tighter labelling for EPO products in cancer patients
- Current biosimilar activity in the rest of the world
- Human Growth Hormone (somatropin)
- What is it?
- Who makes it?
- Developments on the Horizon
- Summary sales data
- Company specific sales data
- Genotropin
- Humatrope
- Norditropin/other Novo Nordisk HGH products
- Nutropin
- Saizen/Serostim
- Bio-Tropin
- Current biosimilar activity
- Current biosimilar activity in the USA
- Accretropin receives FDA approval
- Current biosimilar activity in the European Union
- Biopartners makes Valtropin Phase III data available
- Current biosimilar activity in the rest of the world
- DEA action against Chinese HGH imports
- G-CSF
- What is it?
- Who makes it?
- Developments on the Horizon
- Summary sales data
- Company specific sales data
- Neupogen/Neulasta
- Neutrogin/Granocyte
- Leukine
- Current Biosimilar Activity
- Current biosimilar activity in the USA
- Teva to seek BLA for Tevagrastim in USA?
- Hospira
- Merck BioVentures
- Apotex and Intas announce agreement to develop G-CSF
- Current biosimilar activity in the European Union
- Hospira submits EMEA application in Q109
- CT, ratiopharm and Teva receive EU approval
- Lithuania referred to European Court over Biosimilar G-CSF
- Synageva Biopharma
- 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
- Aventis recombinant insulin products: Lantus, Apidra
- Current biosimilar activity
- Current biosimilar activity in the USA
- Current biosimilar activity in the European Union
- Marvel LifeSciences withdraws EU application
- Current biosimilar activity in the 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
- Current biosimilar activity in the USA
- Current biosimilar activity in the European Union
- EMEA rejects Biopartners‟ Interferon A application
- Biopartners withdraws interferon beta application
- Current biosimilar activity in the rest of the world
- Beyond the first wave
- Etanercept
- Summary sales data - Amgen (USA & Canada)
- Summary sales data - Wyeth (Outside USA & Canada)
- Current Biosimilar activity
- Monoclonal antibodies
- Rituximab
- Summary sales data
- Current Biosimilar activity
- Dr Reddy‟s
- GTC Biotherapeutics/LFB
- 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, 2008
- Regulatory attitude
- National pricing & reimbursement policies
- Interchangeability and substitutability
- 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 position in the USA
- Overview of the US regulatory system
- Hatch-Waxman is not applicable to biologics
- Exceptions
- FDA transfer of biologic responsibility to CDER
- How feasible is the 505(b)(2) route ?
- Omnitrope in the USA
- The FDA‟s reasoning
- FDA Response to Citizen Petitions regarding Omnitrope
- The Scope of Clinical Trials Required for FDA Approval of Omnitrope
- Conclusions regarding the FDA‟s approval of Omnitrope:
- Easier not to seek an abridged application?
- Current Moves in Congress, 2009
- Promoting Innovation and Access to Life Saving Medicine Act (H.R. 1427/S. 726)
- Pathway for Biosimilars Act (H.R. 1548)
- Biologics Price Competition and Innovation Act (formerly S. 1695, now S. 1679, Title VI)
- Interchangeability an option, not a requirement
- Data exclusivity
- Marketing exclusivity
- Resolving patent disputes
- Reaction from industry
- Reaction from the White House
- House Committee releases responses to biosimilar questionnaire
- Data exclusivity
- Interchangeability
- Clinical trials
- Should biosimilars have a separate INN?
- FDA issue product class guidance?
- Should the US follow the EU model?
- Bio responds
- FDA Testimony to Congress, 2007
- FDA Briefing Paper issued, 2007
- Prospects for legislation in 2009
- The position in Europe
- The new EU approval process
- Regulation of biosimilars
- EMEA Guideline Documents
- Current EU biosimilar approvals: somatropin
- Omnitrope
- Valtropin
- BioPartners releases Phase III details for Valtropin
- Current EU biosimilar approvals: EPO
- Sandoz
- Sandoz releases data for Binocrit
- Stada/Hospira
- Hospira presents trial data for Retacrit
- Current EU biosimilar approvals: G-CSF
- Sandoz
- Conclusions
- The position elsewhere
- Other developed markets
- Canada
- Approval of Omnitrope
- Australia and New Zealand
- Japan
- Approval of Omnitrope
- Singapore
- Developing markets
- Why are these markets worth a look?
- India
- Indonesia
- Mexico
- Saudi Arabia
- Thailand
- Who will be the players in the market?
- Manufacturer profiles
- Abraxis BioScience
- Anhui Anke Biotech
- Avesthagen (Avestha Gengrane Technologies)
- AVDESP trial gets go-ahead
- BiotechCorp
- Intas Pharmaceuticals
- Bioclones
- Biocon
- Basalog
- Insugen
- Erypro
- NUFIL
- Abraxis and Biocon announce G-CSF partnership
- Other products
- Biocon buys majority stake in German marketing company
- BioGeneriX
- Merckle Biotech
- Cangene
- Neose Technologies
- BioPartners
- Valtropin
- Sustained release HGH
- Interferon applications rejected by EMEA
- Bioton S.A.
- Cangene
- Accretropin
- Leucotropin
- Cell Therapeutics
- Celltrion
- CIGB (Cuba)
- Cipla
- Biomab
- CheilJedang (CJ Corp)
- Cinnagen
- Claris Lifesciences
- Dr Reddy‘s
- Dongbao Biopharmaceutical
- Elona Biotechnologies
- GTC Biotherapeutics
- AgResearch Ltd
- JCOM
- LFB Biotechnologies
- Hospira
- Distribution deal with Celltrion
- Pliva sells biosimilar rights and facility to Hospira
- Stada Arzneimittel
- BresaGen
- Inno Biologics
- Intas Biopharmaceuticals
- New MAB facility announced
- Intas and Apotex sign G-CSF agreement
- Itero Biopharmaceuticals
- LG Life Sciences
- Marvel Lifesciences
- Merck BioVentures
- Merck acquires Insmed‟s biosimilar portfolio
- Momenta Pharmaceuticals
- NCPC Genetech
- Protalix Biotherapeutics
- Protein Production Services (PPS)
- Reliance Life Sciences
- Sandoz
- Lek
- Sandoz biotech plants, Austria
- Lek biotech plant, Slovenia
- Selexis
- SciGen
- Shreya Biotech
- Chinese JV
- Marketed Products
- Pipeline Products
- Shantha Biotechnics
- 3SBio
- EPIAO
- Other products
- Sales data
- Shenzhen Kexing Biotech
- Simcere
- Stada Arzneimittel
- EPO-zeta gains EU approval
- Synageva Biopharma
- Teva Pharmaceuticals
- G-CSF
- Teva to seek BLA for Tevagrastim in USA?
- Lonza
- Lonza announces new Indian manufacturing site
- Teva to divest Pliva‟s biopharmaceutical activities
- CoGenesys
- Sicor Biotech UAB
- Tianjin Hualida Biotechnology Pharmaceutical Co
- Three Rivers Pharmaceuticals
- Viropro
- Deal with Intas Biopharmaceutical
- Biochallenge agreement signed
- Wockhardt
- Zenotech Laboratories
- Sources
- Directory
- Regulators
- Industry Associations
- Manufacturers
- Index
- INDEX OF TABLES
- Leading EPO Brands, World Sales, 2001-2008 (US$ millions)
- Leading EPO Brands, % Change, 2002-08
- Leading EPO Brands, % of Subtotal, 2001-2008
- J&J Sales of Procrit/Eprex, 2001-2008 (US$ millions)
- Amgen Sales of Epogen/Aranesp, 2001-2008 (US$ millions)
- Amgen EPO Patents in the USA
- Roche Sales of Neorecormon/Epogin, 2002-2008 (SwF millions)
- Manufacturers' summary
- Leading HGH Brands, World Sales, 2001-2008 (US$ millions)
- Leading HGH Brands, % Change (US$ sales), 2002-08
- Leading HGH Brands, % of Subtotal, 2001-2008
- Genotropin Sales, 2001-08 (US$ millions)
- Humatrope Sales, 2001-08 (US$ millions)
- Novo Nordisk HGH Sales, 2001-08 (DKK millions)
- Genentech HGH Sales, 2001-08 (US$ millions)
- Merck/Serono HGH Sales, 2001-2008 (US$ millions)
- Manufacturers' Summary
- Leading G-CSF Brands, World Sales, 2001-2008 (US$ millions)
- Leading G-CSF Brands, % Change 2003-08
- Leading G-CSF Brands, % of Total, 2002-08
- Neupogen/Neulasta Sales, 2001-08 (US$ billions)
- Sales of Neutrogin/Granocyte, 2002-08 (billion yen)
- Manufacturers' Summary
- Leading Human Insulin brands, World Sales, 2001-2008 (US$ millions)
- Leading Human Insulin Brands, % Change, 2002-2008
- Leading Human Insulin Brands, % of Subtotal, 2001-2008
- Sales of Novo Nordisk Insulin Analogues, 2001-2008 (DKK million)
- Sales of Humulin and Humalog, 2001-2008 (US$000s)
- Lantus Sales by Region, 2004-08 (euro millions)
- Manufacturers' Summary
- Leading Interferon Brands, World Sales, 2001-2008 (US$ millions)
- Leading Interferon Brands, % of Subtotal, 2002-2008
- Sales of Intron A and PEG-Intron, 2002-2008 (US$ millions)
- Sales of Pegasys, 2002-08 (SwF millions)
- Sales of Betaseron/Betaferon, 2001-08 (euro millions)
- Sales of Avonex, 2001-08 (US$ millions)
- Sales of Rebif, 2001-08 (US$ millions)
- Manufacturers' Summary
- Summary, factors in favour of the development of biosimilars
- UK NHS Price Comparison, Omnitrope v other HGH Brands, 2008-09
- UK NHS Price Comparison, Ratiograstim v Neupogen, 2009
- UK NHS Price Comparison, EPO 2009
- Human Growth Hormone Prescriptions in England, 2008
- 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)
- FDA Response to Originator Arguments Against Omnitrope
- Omnitrope Phase III Trials Conducted In Support of NDA
- CHMP Guidelines, Drafts & Concept Papers
- Summary Requirements, Chemical Generic v Biosimilars
- Summary of Biosimilar Manufacturers and Products
- 2008 US$ exchange rates used in this report
AbstractWith the prospect of high-profile, high-value biosimilar products on the horizon, the sector is poised to realise its full potential - but only if the US can establish a regulatory pathway. This report addresses key issues and provides insight into how the sector may develop.
Get Full Details About This Report >>
|
|
US: 800.298.5699
Int'l: +1.240.747.3093
|
|
|
