Global Biosimilars: Identifying 2nd Generation Opportunities

Date: January 22, 2011
Pages: 194
Price:
US$ 2,265.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: GBCBBCD0A93EN
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Global Biosimilars: Identifying 2nd Generation Opportunities
With a US regulatory pathway in place, albeit untried and untested, the path is clear for serious consideration of the opportunities in biosimilars as a global business.

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:

2nd generation products will drive growth and interest The biosimilar industry can launch itself on half a dozen older products, but it is not going to thrive on them alone. In order to grow, it will need to look ahead to developing similar versions of newer biologic products. Initially, this effort will probably concentrate on improving versions of the first generation products, with techniques such as glycolysation or pegylation. Beyond that, there is a large and growing number of biologics, principally in the oncology and CNS fields, which are appearing on the market. These tend to be expensive, causing funding difficulties for governments and health payers. Some have been on the market for a decade, and patent expiry is looming.

US regulatory deal unlikely to unlock the floodgates President Obama signed the health reform bill (H.R. 3590) into law on 23rd March 2010 which allows for the application of a biological product as a biosimilar and brings to a conclusion a long and hard-fought debate. So it's all good? According to the FDA it “immediately” formed a working group to consider the implementation, the first public hearing taking place 8 months after the Act was signed and against a background of wide consultation. Is this caution or ambivalence? There is a mounting cost saving argument as the Congressional Budget Office estimates the US could save US$25 billion. This remains a key issue: more biologics are prescribed in the US than anywhere else.

Emerging markets – a better bet? One consequence of rapid economic growth in emerging markets has been a reduction of deaths from infectious disease in childhood, and longer life expectancy as a result. This has brought with it a rise in the incidence of more ""western"" diseases, such as diabetes or cancer, and is the reason that countries such as India are keen to develop affordable versions of biologic drugs in order to be able to treat more people in their home markets and ultimately overseas – is it any wonder that the Indian biosimilar industry is so progressive?

What is the biosimilar market worth?

Establishing a reliable value of the biosimilar market is problematical, and estimates have varied widely.

This report forecasts that for EPO, G-CSF and HGH, total biosimilar product sales by 2015 are estimated at US$342 million, of which US$159 million is in the USA and US$183 million outside it. EPO is the largest product category, at US$230 million in total. Beyond 2015, new products will appear which will significantly increase these estimates.

Global Biosimilars: Identifying 2nd generation opportunities is a new, critical 190+ page management report, published in January 2011 by leading generic industry publisher Espicom Business Intelligence. This strategic report addresses the key issues of concern and provides insights into how the sector may practically develop.
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)
Global Biosimilars: Identifying 2nd generation opportunities
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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