Biosimilars: Beyond the first product wave

Date: October 22, 2009
Pages: 218
US$ 2,265.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: BF36D35339BEN

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Biosimilars: Beyond the first product wave
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.


What is a biologic drug?
What’s in a name?
Why are Biosimilars an issue?


Erythropoietin (Epoetin, EPO)
  What is it?
  Who makes it?
  Developments on the Horizon
      EU Approval for Mircera
  Summary sales data
  Company-specific sales data
  Current biosimilar activity
    Current biosimilar activity in the USA
    Current biosimilar activity in the EU
      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


What is it?
Who makes it?
Developments on the Horizon
Summary sales data
Company specific sales data
  Norditropin/other Novo Nordisk HGH products
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


What is it?
Who makes it?
Developments on the Horizon
Summary sales data
Company specific sales data
Current Biosimilar Activity
  Current biosimilar activity in the USA
    Teva to seek BLA for Tevagrastim in USA?
    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


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


What is it?
Who makes it?
Summary sales data
Company specific sales data
  Schering Plough Interferon A (Intron A range)
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


  Summary sales data – Amgen (USA & Canada)
  Summary sales data – Wyeth (Outside USA & Canada)
  Current Biosimilar activity
Monoclonal antibodies
    Summary sales data
    Current Biosimilar activity
      Dr Reddy's
      GTC Biotherapeutics/LFB


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
  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


Overview of the US regulatory system
Hatch-Waxman is not applicable to biologics
  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
    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 new EU approval process
Regulation of biosimilars
  EMEA Guideline Documents
    Current EU biosimilar approvals: somatropin
    BioPartners releases Phase III details for Valtropin
  Current EU biosimilar approvals: EPO
    Sandoz releases data for Binocrit
    Hospira presents trial data for Retacrit
  Current EU biosimilar approvals: G-CSF


Other developed markets
  Approval of Omnitrope
Australia and New Zealand
  Approval of Omnitrope
Developing markets
  Why are these markets worth a look?
    Saudi Arabia


Manufacturer profiles
  Abraxis BioScience
  Anhui Anke Biotech
  Avesthagen (Avestha Gengrane Technologies)
    AVDESP trial gets go-ahead
    Intas Pharmaceuticals
      Abraxis and Biocon announce G-CSF partnership
    Other products
    Biocon buys majority stake in German marketing company
    Merckle Biotech
    Neose Technologies
      Sustained release HGH
    Interferon applications rejected by EMEA
  Bioton S.A.
  Cell Therapeutics
  CIGB (Cuba)
  CheilJedang (CJ Corp)
  Claris Lifesciences
  Dr Reddy‘s
  Dongbao Biopharmaceutical
  Elona Biotechnologies
  GTC Biotherapeutics
    AgResearch Ltd
    LFB Biotechnologies
    Distribution deal with Celltrion
    Pliva sells biosimilar rights and facility to Hospira
    Stada Arzneimittel
  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 biotech plants, Austria
    Lek biotech plant, Slovenia
    Shreya Biotech
    Chinese JV
    Marketed Products
    Pipeline Products
  Shantha Biotechnics
    Other products
    Sales data
  Shenzhen Kexing Biotech
  Stada Arzneimittel
    EPO-zeta gains EU approval
  Synageva Biopharma
  Teva Pharmaceuticals
      Teva to seek BLA for Tevagrastim in USA?
    Lonza announces new Indian manufacturing site
  Teva to divest Pliva's biopharmaceutical activities
  Sicor Biotech UAB
    Tianjin Hualida Biotechnology Pharmaceutical Co
  Three Rivers Pharmaceuticals
    Deal with Intas Biopharmaceutical
    Biochallenge agreement signed
  Zenotech Laboratories



Industry Associations



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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