Global Biosimilars: A return to optimism?

Date: January 23, 2012
Pages: 200
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Global Biosimilars: A return to optimism?
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
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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