Global Biosimilars

Global Biosimilars

A return to optimism?

Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies - and some surprising names - are positioning themselves for market entry.

Examining the market for companies

The need for a settled market environment is essential if the growing numbers of biologic products losing patent protection in the next 5-10 years is to be exploited. However, progress is painfully slow and critical issues driving the market dynamic include:

Industry investment: a sign of confidence?

This report provides a detailed analysis of 50 companies active in the biosimilars field, many of which have declared their interest in 2011. The move may reflect a growing confidence that as regulatory provision for biosimilars increases, and as the pipeline of prospective products matures, then the prospect of actually being able to launch products grows more realistic.

The US continues to disappoint; Europe forges ahead

Despite President Obama's health reform bill being passed in 2010, very little has happened. And the FDA's cautious approach suggests little will happen in the immediate future. The much anticipated Guidance, expected in 2011 has failed to appear, and in May 2011 FDA published details for User Fees - a scheme that will not come into effect (assuming it is passed by Congress) until 2013. Given that an untried regulatory system will not operate at the fastest speed then prospects of a US market for advanced biosimilars seem remote before 2015. In contrast, European regulators are revising their widely-adopted regulations in the light of experience, with a view to issuing revisions and guidance in 2012.

Developing markets may offer a profitable alternative

Developing markets with rising disposable incomes may present the medium-term prospect for biosimilars, since they combine a large target population with reduced operating costs. Many countries are following the EU model of regulation. Markets such as India and China have plenty of home-grown production capacity. Some companies have sought to turn this capacity to their advantage, and have signed deals with Chinese/Indian producers for the development of products to be sold around the world.

This report provides a comprehensive insight to the market environment, current and future products and the companies involved.

• A complete examination of the regulatory situation in the US, Europe and emerging markets
• Detailed assessment of current biosimilar products and developers with market share by product
  • EPO
  • G-CSF
  • HGH
  • Human Insulin
  • Interferon (alfa & beta)
• Identification and analysis of likely second wave of advanced biologics to come to the market
  • Adalimumab
  • Etanercept
  • Infliximab
  • Rituximab
  • Trastuzumab
• A review of operational issues that will affect the adoption of biosimilars including pricing/reimbursement, clinician attitudes and patient acceptance
• The position, activity, products, pipeline and plans of 50 leading players in the field

The Challenge for Industry

The development of a biosimilar presents a series of challenges to traditional generic drug manufacturers seeking to enter the sector. To succeed, a company must have good financial backing. Small companies will be able to do the science, but the cost of product development and approval will generally exceed the resources of most chemical generic organisations. After this, there is the cost of marketing and post-market surveillance. There is little prospect in the EU and USA of biosimilars being sold unbranded and biosimilar developers will have to pay for the branding and the marketing of the products; a task for which many lack the funds, sales force and experience.

Corporate manoeuvring is seeing the competitive landscape change

Despite the challenges there has been an upsurge in company activity, most notably from the branded industry and from companies who have no current significant pharmaceutical interests. With the regulatory situation generally favourable to the branded industry, why are they interested?

There are three broad reasons why an originator would wish to become involved with biosimilars. Firstly, it would create a more diversified portfolio, an important consideration in an era of near-dry pipelines. Secondly, it would potentially allow for the development of expertise in the biologic area for companies which traditionally have limited involvement in biologics. Thirdly, it could potentially act as a "spoiler" operation by making the market environment more difficult for smaller biosimilar developers.

Among recent corporate developments

• Pfizer and Biocon announced a deal in October 2010 for the development and worldwide commercialisation of Biocon's recombinant insulin products.
• Boehringer Ingelheim announced the establishment of a separate biosimilar business in September 2011.
• Amgen and Watson announced a deal for the development of biosimilar versions of non-Amgen biologic products in December 2011.
• Baxter and Momenta Pharmaceuticals announced a joint-venture for the development of biosimilars in December 2011.
• Biogen Idec announced a joint-venture deal with the Korean conglomerate, Samsung, for the development of biosimilars. This will not include biosimilars of Biogen Idec products.
• Fujifilm have indicated they will create a joint-venture for the development of biosimilars in 2012.

Competitive Assessment

50 Leading players reviewed

• 3SBio
• Actavis
• Amgen
• Avesthagen
• Bioclones
• Biocon
• Biogen Idec
• Biolex Therapeutics
• BioPartners
• Bioton
• Boehringer Ingelheim
• Cangene
• Cell Therapeutics
• Celltrion
• CIGB
• Cinnagen
• Cipla
• CJ Corp
• Claris Lifesciences
• Dr Reddy's
• Elona Biotechnologies
• Gennova Biopharmaceuticals
• Getz Pharma
• GTC Biotherapeutics
• Hospira
• Inno Biologics
• Intas Biopharmaceuticals
• Itero Biopharmaceuticals
• LG Life Sciences
• Merck & Co
• MJ Biopharma
• Momenta Pharmaceuticals
• Mycenax Biotech
• Mylan
• Pfizer
• Protalix
• Reliance Life Sciences
• Samsung
• Sandoz
• SciGen
• Selexis
• Shantha Biotechnics
• Simcere/Shanghai Celgen
• Stada Arzneimittel
• Teva Pharmaceutical Industries
• Three Rivers Pharmaceuticals
• Viropro
• Watson
• Wockhardt
• Zenotech Laboratories

Contents

Foreword

Executive Summary

• What is a biologic drug?
• What's in a name?
  • Biobetters
• 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/Tev-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
  • Merck & Co (formerly Schering-Plough) Interferon A (Intron A range)
  • Betaseron/Betaferon
  • Avonex
  • Rebif
• Current Biosimilar Activity
  • USA
  • European Union
  • Rest of the World

Beyond the First wave

• Etanercept
  • Amgen gains new patent for 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
• Regulatory attitude
• National pricing & reimbursement policies
  • Interchangeability and substitutability
  • Norway makes biosimilar G-CSF switchable - then changes its mind
• Extent of existing competition
  • 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
    • White House seeks to lower data exclusivity period
  • Patent dispute resolution
  • User fees
• Implementation of the BCPIA
  • Slow progress in 2011

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?
  • Brazil
  • India
  • Indonesia
  • Mexico.
  • Saudi Arabia
  • Thailand
  • Vietnam

Who will be the players in the market?

• Current Market Leaders
  • Sandoz
    • Omnitrope
    • Binocrit
    • Zarzio
    • Rituximab
    • 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
    • Kemwell Biopharma
    • 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
  • BioPartners
  • Bioton
  • Gedeon Richter
    • Mochida
    • Stada Arzneimittel
  • 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
    • Sandoz collaboration
    • Baxter joint venture
  • Mylan
    • Marketing Deal with Biocon
  • Three Rivers Pharmaceuticals
  • Viropro
  • Watson
    • Itero and Watson announce rFSH agreement
• 'Big Pharma' Companies
  • Amgen
  • Biogen Idec
  • Boehringer Ingelheim
  • Merck & Co
    • Former Insmed G-CSF products
    • Merck discontinues EPO project
    • Deal signed for etanercept
  • Pfizer
    • Insulin deal with Biocon

Sources

Directory

• Regulators
• Industry Associations
• Manufacturers

Index

INDEX OF TABLES

• Leading EPO Brands, World Sales, 2001-2010 (US$ millions)
• Leading EPO Brands, % Change in Sales, 2002-2010
• Leading EPO Brands, % of Subtotal, 2001-2010
• J&J Sales of Procrit/Eprex, 2001-2010 (US$ millions)
• Amgen Sales of Epogen/Aranesp, 2001-2010 (US$ millions)
• Amgen EPO Patents in the USA
• Roche Sales of Neorecormon/Epogin, 2002-2010 (SwF millions)
• Biosimilar EPO: manufacturers' summary
• Leading HGH Brands, World Sales, 2001-2010 (US$ millions)
• Leading HGH Brands, % Change (US$ sales), 2002-2010
• Leading HGH Brands, % of Subtotal, 2001-2010
• Genotropin Sales, 2001-2010 (US$ millions)
• Humatrope Sales, 2001-2010 (US$ millions)
• Novo Nordisk HGH Sales, 2001-2010 (DKK millions)
• Roche/Genentech HGH Sales, 2001-2010 (US$ millions)
• Merck/Serono HGH Sales, 2001-2010 (US$ millions)
• Biosimilar HGH: Manufacturers' Summary
• Leading G-CSF Brands, World Sales, 2001-2010 (US$ millions)
• Leading G-CSF Brands, % Change 2003-2010
• Leading G-CSF Brands, % of Total, 2002-2010
• Neupogen/Neulasta Sales, 2001-2010 (US$ billions)
• Sales of Neutrogin/Granocyte, 2002-2010 (billion yen)
• Biosimilar G-CSF: Manufacturers' Summary
• Leading Human Insulin brands, World Sales, 2001-2010 (US$ millions)
• Leading Human Insulin Brands, % Change, 2002-2010
• Leading Human Insulin Brands, % of Subtotal, 2001-2010
• Sales of Novo Nordisk Insulin Analogues, 2001-2010 (DKK million)
• Sales of Humulin and Humalog, 2001-2010 (US$000s)
• Biosimilar Human Insulin: Manufacturers' Summary
• Leading Interferon Brands, World Sales, 2001-2010 (US$ millions)
• Leading Interferon Brands, % of Subtotal, 2002-2010
• Sales of Intron A and PEG-Intron, 2002-2010 (US$ millions)
• Sales of Pegasys, 2002-2010 (SwF millions)
• Sales of Betaseron/Betaferon, 2001-2010 (euro millions)
• Sales of Avonex, 2001-2010 (US$ millions)
• Sales of Rebif, 2001-2010 (US$ millions)
• Biosimilar Interferons: Manufacturers' Summary
• Summary, factors in favour of the development of biosimilars
• UK NHS Price Comparison, Omnitrope v other HGH Brands, 2009-11
• UK NHS Price Comparison, Ratiograstim v Neupogen, 2009-11
• UK NHS Price Comparison, EPO 2010
• UK NHS Price Comparison, EPO 2011
• 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
• 2010 US$ exchange rates used in this report

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