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Published by: Espicom Healthcare Intelligence
Published: Sep. 9, 2008 - 210 Pages
Table of Contents
- Foreword
- Executive Summary
- What is a biologic drug?
- What’s in a name?
- Why are Biosimilars an issue?
- The current state of the market for each of the major products
- 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
- 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 of the Horizon
- Summary Sales data
- Company specific sales data
- Neupogen/Neulasta
- Neutrogin/Granocyte
- Leukine
- Current Biosimilar Activity
- Current biosimilar activity in the USA
- Insmed
- Apotex and Intas announce agreement to develop G-CSF
- Current biosimilar activity in the European Union
- CT, ratiopharm and Teva receive positive opinions
- Lithuania referred to European Court over Biosimilar G-CSF
- 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
- EMEA issues concept paper for biosimilar Interferon A
- Biopartners submits Interferon beta to EMEA
- Current biosimilar activity in the rest of the world
- Beyond the First wave
- Monoclonal Antibodies
- Rituximab
- Summary sales data
- Current Biosimilar activity
- Dr Reddy‘s
- GTC Biotherapeutics/LFB
- Factors in favour
- Rising cost of healthcare
- US pharmaceutical expenditure increases
- Factors against
- Science
- The INN naming issue
- EBE-EFPIA position paper on naming of biosimilars
- Response from the generic industry
- USP publishes monographs on somatropin
- No strict definition of a biologic
- High cost of development and marketing
- Product complexity
- Will manufacturers have sufficient capacity?
- Detail of regulatory requirements
- Different international requirements
- Postmarket surveillance requirements.
- Marketing requirements
- Regulatory obstacles
- US pathway still a long way off
- What does the FDA really think?
- Legal problems
- Patent challenges
- Exclusivity of test data
- Product acceptance
- Interchangeability and substitutability
- Does biosimilar = obsolete?
- Is there a commercially viable market?
- Just what will the savings from biosimilars be?
- PCMA
- Express Scripts
- Avalere report
- Insmed releases report on cost savings
- CBO issues report on impact of biosimilars
- Originator Strategies to Combat Biosimilars
- The position in the USA
- 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?
- Moves in Congress
- Access to Life Saving Medicine Act (HR. 1038, S. 623)
- Patient Protection and Innovative Biologic Medicines Act of 2007 (HR. 1956)
- Biologics Price Competition and Innovation Act of 2007 (S. 1695)
- Interchangeability an option, not a requirement
- Data exclusivity
- Marketing exclusivity
- Resolving patent disputes
- Pathway for Biosimilars Act (HR. 5629)
- Determination of interchangeability
- Originator market exclusivity
- FDA required to issue guidance documents
- Patent dispute resolution process
- 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?
- Prospects for legislation
- Originator support for stringent legislation
- Biosimilar industry more cautious
- What will the final legislation look like?
- When will it appear?
- FDA Testimony to Congress
- State Governors urges FDA to publish guidance, August 2006
- FDA Briefing Paper issued
- Conclusion
- The position in Europe
- The new EU approval process
- Regulation of biosimilars
- EMEA Guideline Documents
- EPO
- G-CSF
- Somatropin
- rH Insulin
- Interferon alfa
- The first EU biosimilar approvals: somatropin
- Omnitrope
- Omnitrope listed in the UK BNF
- Valtropin
- BioPartners releases Phase III details for Valtropin
- Sandoz receives EPO approvals, 2007
- Stada and Hospira receive EPO approval
- Hospira presents trial data for Retacrit
- EMEA issues positive opinions for biosimilar G-CSF
- Attitudes to Biosimilars: UK Parliamentary Panel Reports
- MHRA issues biosimilar prescribing guidance
- Potential use of biosimilars in the NHS
- Panel recommendations
- Conclusions
- The position elsewhere
- Other developed markets
- Canada
- Australia and New Zealand
- Japan
- Developing markets
- Why are these markets worth a look?
- India
- Indonesia
- Saudi Arabia
- Thailand
- Who will be the players in the market?
- Manufacturer profiles
- Abraxis BioScience
- Anhui Anke Biotech
- Barr Pharmaceuticals
- Pliva agreement for G-CSF
- Bioclones
- Biocon
- Insugen
- Abraxis and Biocon announce G-CSF partnership
- Biocon buys majority stake in German marketing company
- BioGeneriX
- Merckle Biotech
- Cangene
- Neose Technologies
- BioPartners
- Bioton S.A.
- Cangene
- Accretropin
- Leucotropin
- Cell Therapeutics
- CIGB (Cuba)
- Cipla
- CheilJedang (CJ Corp)
- Claris Lifesciences
- Dr Reddy‟s
- Dongbao Biopharmaceutical
- Dragon Pharmaceuticals
- GeneScience Pharmaceuticals
- GTC Biotherapeutics
- Deal with LFB Biotechnologies
- Hospira
- Mayne Pharma
- Stada Arzneimittel
- BresaGen
- Inno Biologics
- Insmed
- Intas Biopharmaceuticals
- Intas and Apotex sign G-CSF agreement
- Itero Biopharmaceuticals
- LG Life Sciences
- Marvel Lifesciences
- Momenta Pharmaceuticals
- NCPC Genetech
- Pliva
- EPO, Croatian approval granted
- G-CSF, agreement with Barr Laboratories
- Mayne Pharma
- New biotech facility announced
- Ranbaxy
- G-CSF Agreement with Zenotech
- Ranbaxy launches ‗bio-generic‘ osteoporosis treatment
- Reliance Life Sciences
- GeneMedix
- RLS acquisition
- Sandoz
- Lek
- Sandoz biotech plants, Austria
- Lek biotech plant, Slovenia
- SciGen
- Shreya Biotech
- Chinese JV
- Marketed Products
- Pipeline Products
- Shantha Biotechnics
- 3SBio
- EPIAO
- Other products
- Sales data
- Shenzhen Kexing Biotech
- Stada Arzneimittel
- EPO-zeta gains EU approval
- Teva Pharmaceuticals
- G-CSF
- Stada Arzneimittel?
- Teva set to acquire Barr
- Teva acquires CoGenesys
- Sicor
- Tianjin Hualida Biotechnology Pharmaceutical Co
- Three Rivers Pharmaceuticals
- Viropro
- Deal with Intas Biopharmaceutical
- Biochallenge agreement signed
- Wockhardt
- Zenotech Laboratories
- Conclusions
- Sources
- Directory
- Regulators
- Industry Associations
- Manufacturers
- Index
- INDEX OF TABLES
- Leading EPO Brands, World Sales, 2001-2007 (US$ millions)
- Leading EPO Brands, % Change, 2002-07
- Leading EPO Brands, % of Subtotal, 2001-2007
- J&J Sales of Procrit/Eprex, 2001-2007 (US$ millions)
- Amgen Sales of Epogen/Aranesp, 2001-2008 (US$ millions)
- Amgen EPO Patents in the USA
- Roche Sales of Neorecormon/Epogin, 2002-2007 (SwF millions)
- Manufacturers' summary
- Leading HGH Brands, World Sales, 2001-2007 (US$ millions)
- Leading HGH Brands, % Change (US$ sales), 2002-07
- Leading HGH Brands, % of Subtotal, 2001-2007
- Genotropin Sales, 2001-07 (US$ millions)
- Humatrope Sales, 2001-07 (US$ millions)
- Novo Nordisk HGH Sales, 2001-07 (DKK millions)
- Genentech HGH Sales, 2001-06 (US$ millions)
- Merck/Serono HGH Sales, 2001-2007 (US$ millions)
- Manufacturers' Summary
- Leading G-CSF Brands, World Sales, 2001-2007 (US$ millions)
- Leading G-CSF Brands, % Change 2003-07
- Leading G-CSF Brands, % of Total, 2002-07
- Neupogen/Neulasta Sales, 2001-07 (US$ billions)
- Sales of Neutrogin/Granocyte, 2002-07 (billion yen)
- Manufacturers' Summary
- Leading Human Insulin brands, World Sales, 2001-2007 (US$ millions)
- Leading Human Insulin Brands, % Change, 2002-2007
- Leading Human Insulin Brands, % of Subtotal, 2001-2007
- Sales of Novo Nordisk Insulin Analogues, 2001-2007 (DKK million)
- Sales of Humulin and Humalog, 2001-2007 (US$000s)
- Lantus Sales by Region, 2004-07 (euro millions)
- Manufacturers' Summary
- Leading Interferon Brands, World Sales, 2001-2007 (US$ millions)
- Leading Interferon Brands, % of Subtotal, 2002-2007
- Sales of Intron A and PEG-Intron, 2002-2007 (US$ millions)
- Sales of Pegasys, 2002-07 (SwF millions)
- Sales of Betaseron/Betaferon, 2001-07 (euro millions)
- Sales of Avonex, 2001-07 (US$ millions)
- Sales of Rebif, 2001-07 (US$ millions)
- Manufacturers' Summary
- Summary, factors in favour of the development of biosimilars
- US Research-Based Pharmaceutical Manufacturers' Sales, 1990-2006 (US$ millions)
- US Pharmaceutical Expenditure as % of GDP, 1990-2006
- Growth of Medicaid Pharmaceutical Expenditure, 1997-2005 (US$ millions)
- FDA Response to Originator Arguments Against Omnitrope
- Omnitrope Phase III Trials Conducted In Support of NDA
- Adopted Guidelines
- Documents submitted for ongoing comment
- CHMP Concept Papers, 2006
- Summary Requirements, Chemical Generic v Biosimilars
- Summary of Biosimilar Manufacturers and Products
- 2007 US$ exchange rates used in this report
AbstractProviding…
A thorough review of the latest regulatory situation in the USA, Europe and selected markets
An examination of products that are currently available for development:
- EPO
- HGH
- G-CSF
- Human Insulin
- Interferon
A review of key issues such as development costs and legal matters
Consideration of upcoming product opportunities
Examination of the factors such as pricing and clinician response
A review of the work of 42 companies actively developing biosimilar products
The promise of profits from biosimilars grows greater, but only when a number of significant market, regulatory and clinical hurdles can be overcome.
The future of the pharmaceutical industry lies with biotechnology. Biotech drugs account for around 10-15% of the current pharmaceutical market, and the sector is outperforming the market as a whole in terms of growth.
The need for a settled market environment is essential if the growing number of products which will lose patent protection in the next 5 years can be exploited. However, progress is painfully slow and the focus is now on three critical issues.
US regulatory impasse
Wrangling between the FDA, Congress and vested interests and the continuing lack of a regulatory pathway for biosimilars in the USA is stifling market expansion domestically and globally. When this is resolved currently available biosimilar products will have a market of volume and value and competition will increase.
Product range expansion
The current products are specialist and treat relatively few conditions at high cost. However, second generation products, including monoclonal antibodies indicated for high value conditions with unmet clinical need, such as cancer, will be more attractive to manufacturers.
Clinical acceptance
Biological drugs are complicated, expensive products used to treat complex conditions. Given this, it may be difficult for manufacturers to persuade physicians to prescribe and use generic versions. In some countries, such as France or Japan, prescribing of chemical generics is relatively unpopular, so the task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter.
How this pans out in the future is crucial for the whole market. When will a significant biosimilar market develop? Could an abridged regulatory process really benefit generic manufacturers? Is there a political will to change the status quo in the US? Will physicians be the final arbiters of the sector’s success? Biosimilars: a viable market -but when? is a critical 200-page management report, published in September 2008 by leading generic industry publisher Espicom Business Intelligence which addresses these and other key issues of concern.
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