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시장보고서
Biosimilars: Beyond the first product wave
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Abstract
With 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.
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 losing patent protection in the next 5 years is to be exploited.
However, progress is painfully slow and the focus is now on three critical
issues:
US regulatory deal more likely than ever before
The continued 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. Agreement is, however, more likely
in 2009 than at any time before, but even if legislation is passed, it is
unclear how sympathetic it will be to the economically viable development of
biosimilars in the USA. With a wider portfolio of products becoming available
there is a mounting cost saving argument as the Congressional Budget Office
estimates the US could save US$25 billion from the use of biosimilars over 10
years.
A more valuable product range is on the horizon
The current biosimilar products are relatively low cost. However, second
generation products, including monoclonal antibodies indicated for high-value
conditions such as cancer and CNS, will be more attractive to manufacturers.
Clinical acceptance - a determining factor?
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 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 pharmaceutical
market. Biosimilars: Beyond the first product wave is a new, critical 200-page
management report, published in October 2009 by leading generic industry
publisher Espicom Business Intelligence, which addresses these and other key
issues of concern and provides insight into how the sector may develop.
- When will a significant biosimilar market develop?
- Could an abridged regulatory process really benefit biosimilar
manufacturers?
- Will biosimilars be undermined by a price war?
- Is there political will to find a solution in the US?
- Will doctors' attitudes be key to the sector' s success?
The biosimilar sector continues to attract huge interest and controversy. Most
generic manufacturers are actively involved in it, either directly or
indirectly. The successful ones will be those with the patience, resources and
above all money to invest now, in order to gain in the future. Even for the
vanguard, however, those gains are some years off.
Providing...
- 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
- Analysis of upcoming product opportunities such as Biogen Idec/Roche' s
rituximab and Amgen/Wyeth' s etanercept
- 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 47 companies actively developing biosimilar
products
About the Author
The report has been written by Espicom' s Chief Healthcare Markets Analyst,
Andy Crofts.
Andy has over 12 years experience of analysing pharmaceutical and healthcare
markets, with a particular interest in global generic pharmaceuticals. He is
editor of a range of Espicom' s leading market analysis services, including
World Pharmaceutical Markets, World Generic Markets and Generic Companies
Analysis.
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
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
- 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
- Conclusions
The position elsewhere
- Other developed markets
- Canada
- Australia and New Zealand
- Japan
- 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
- Interferon applications rejected by EMEA
- Bioton S.A.
- Cangene
- Cell Therapeutics
- Celltrion
- CIGB (Cuba)
- Cipla
- 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
- Lonza
- Lonza announces new Indian
- Teva to divest Pliva - s biopharmaceutical
- CoGenesys
- Sicor Biotech UAB
- Tianjin Hualida Biotechnology
- 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
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