Biosimilars: A Growing Market

An overview of developments, companies & commercial opportunities

Publication Date March 2010
ISBN 978-1-905751-18-1
Pages 60
Tables 9
Figures 7

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The biologicals segment has been the fastest growing segment of the pharmaceuticals market in recent years, with sales of the leading products (not including insulins) collectively reaching $60 billion.

Although a number of major companies have significant biological capabilities, few apart from Novartis have yet clearly developed strategies to compete in the biosimilars market

Since Sandoz pioneered the development of biosimilar drugs in 2001 there has been a steady breakdown of regulatory resistance. However, there are considerable entry barriers hindering companies that wish to enter this field of therapeutics.

Biosimilars – A Growing Market is a unique report from URCH Publishing that provides the reader with a comprehensive review of the current and future market for biosimilar products,

Some key findings from the report:

  • Few companies apart from Novartis have yet clearly developed strategies to compete in the biosimilars market. 
  • The biosimilars market segment is poorly developed but is expected to become a significant commercial segment capturing a healthy percentage share of the biologicals market. 
  • Many forecasts of the biosimilars market are over-optimistic, and assume a rapid resolution of the legislative impasse in the US and overlook the strength of Amgen’s patent position with respect to epoetin alfa. 
  • Assuming a later passing of US legislation the value of the biosimilars market segment will continue to be dominated by European sales revenues in 2012, and this is likely to account for about 0.6% of the fast-growing biologicals market.
  • The anti-TNF segment offers the best commercial opportunity with the three leading products all likely to face competition from biosimilars in Europe by 2016.

Report Structure

Chapter 1 focuses on the development history of biosimilars and provides an overview of the environment.

Chapter 2 considers the progress towards the development of approval pathways for this class of agents in the US and Japan, together with the current European framework. It also briefly addresses the position in other markets.

Chapter 3 discusses the substantial hurdles that must be surmounted by those companies that wish to develop and market biosimilars. And these are additional to the regulatory hurdles that are discussed in chapter 2.

Chapter 4 examines the blossoming European market for biosimilars. The regulatory barriers to their approval in both Japan and the US have ensured that few biosimilars are yet available in those markets.

Chapter 5 highlights the key factors that suggest that the successful development and marketing of a biosimilar product is commercially advantageous. It also covers, subject to the availability of suitable enabling legislation in the US and Japan, which biosimilars products might enter the market.

Chapter 6 analyses the impact of biosimilars upon specialist, generic and market pharmaceutical companies. A number of key companies are profiled.

Chapter 7 looks to the future and considers which factors will impact the market for biosimilars. The high cost of these products and the increasing pressure that they place on healthcare budgets is likely to prove a major driver in the adoption and uptake of biosimilars, even in the US market.

The report concludes by assessing the market outlook over the period 2010–20, which is forced to rely on certain key assumptions owing to current uncertainties as to when biosimilar products will become available in the US.

Companies mentioned in the report include:

3SBio, Abbott, Amgen, AnGes, AstraZeneca, Barr Pharmaceuticals, Bayer Schering, Bharat Biotech, Bioceuticals, Biocon, Biogen Idec, Bioton, Cambridge Antibody Technology, Celgene, Chugai, Daiichi Sankyo, Dainippon Sumitomu, r Reddy’s, Dragon Pharmaceuticals, Eisai, Eli Lilly, Genentech, Genzyme, Hospira, ImClone, Intas Pharmaceuticals,Johnson & Johnson, Kyowa Hakko Kirin, LG Life Sciences, Lonza AG, MedImmune, Merck, Merck Serono, Mitsubishi Tanabe, Mylan, Neulasta, Novartis (Sandoz), Panacea Biotec, Pfizer, PharmAthene, Ranbaxy, Raptiva,  Ratiopharm, Roche, Roche/Genentech, Schering-Plough, Shantha, Biotechnics, Stada, Takeda, Teva, Toray, UCB, Wockhardt, Wyeth, Xoma

Drugs mentioned in the report include:

Abseamed, Actemra, Aldurazyme, Aranesp, Avastin, Avonex, Betaseron, Binocrit, Cerezyme, Cimzia, Enbrel, Epoetin, Epogen, ESPO, Feron, Glaritus, Granocyte, Herceptin, Humira, IntronA, Lucentis, Macrogen, Mircera, Myozyme, Naglazyme, NeoRecormon, Nesp, Neugranin, Neulasta, Neupogen, NuGraf, Omnitrope, Pegasys, PegIntron, Procrit, Ratiograstim, Rebif, Reditux, Remicade, Replagal, Revlimid, Rituxan, Roferon-A, Synagis

Executive Summary

Chapter 1: Introduction
Introduction
Drugs and generics
Biological products
What is a biosimilar?
Developments, 2000-09
New commercial opportunities

Chapter 2: Approval of Biosimilars
Overview
Europe
Data requirements
Assessment process
US
The FDA
FTC
Congress
Assessment of the position
Japan
Other markets

Chapter 3: Entry Barriers
Contrast to conventional generics
Development issues
Manufacturing issues
Patent considerations
Distribution channels
Price impact

Chapter 4: The Emergent European Market in Biosimilars
Introduction
Current status
Rejected applications
Human growth hormone biosimilars
Erythropoietin biosimilars
Filgrastim biosimilars
Impending launches
Current assessment

Chapter 5: Significant Commercial Opportunities
Introduction
Leading biotechnology products
When do current biotechnology products go off patent?
Europe
US
Epoetin litigation
Japan
Summary of opportunities
Market assessment

Chapter 6: Strategic Developments
Introduction
New specialist companies
3SBio
Bharat Biotech
Biocon
Bioton
Dragon Pharmaceuticals
Intas Pharmaceuticals
Lonza AG
Panacea Biotec
Reliance Life Sciences
Shantha Biotechnics
Response of the generics companies
Novartis (Sandoz)
Dr Reddy's
Hospira
LG Life Sciences
Mylan
Ranbaxy
Ratiopharm
Stada
Teva
Wockhardt
Big pharma's response
AstraZeneca
Merck
Pfizer
Overview

Chapter 7: Market Outlook
Commercial factors
Biosimilar substitution
Pricing
Cost savings
Strategic drivers
Emerging opportunities
Europe
US
Japan
Commercial overview
Epoetins
G-CSF
Interferons
Anti-TNF products
Oncology and other antibodies
Financial forecast


List of Figures
Figure 1.1 2008 sales and year of launch of leading biological products
Figure 2.1 Market exclusivity for reference products and timing of biosimilar Marketing Authorisation Applications (MAAs)
Figure 2.2 Centralised procedure for MAAs
Figure 2.3 Number of new biologics approved in Japan, 2001-08
Figure 4.1 Biosimilar MAAs submitted for initial evaluation
Figure 5.1 Worldwide sales of biological products by patent expiration year and 2008 revenues of those products
Figure 5.2 Approval of new biological agents in Japan, 2001-08

List of Tables
Table 2.1 Quantity of data required for MAAs for generic and biosimilar products (as number of lever-arch files)
Table 2.2 Data requirements for MAAs for generic and biosimilar products
Table 5.1 Leading biotechnology therapeutics (excluding insulin derivatives and vaccines) showing reported global sales for 2007 and 2008
Table 5.2 Top 11 classes of biotechnology therapeutics (excluding vaccines) showing reported global sales for 2007 and 2008
Table 5.3 Expiration dates of market exclusivity of key biological products in the major European countries
Table 5.4 Expiration dates of market exclusivity of key biological products in the US
Table 5.5 Amgen's key epoetin patents in the US
Table 5.6 Approval dates of selected biological products in Japan
Table 7.1 Timeline of anticipated key events, 2010-17 (those in the US and Japan assume that legislation is enacted as discussed)


Peter Norman is a pharmaceutical consultant and analyst based in England, with specialist knowledge of the respiratory disease and inflammation markets. He has written and presented widely on various aspects of respiratory disease, on the analysis of diverse therapeutic segments, and on Orphan Drugs. Dr Norman has 30 years’ experience of the pharmaceutical industry in both R&D and competitive intelligence. His publications include many reviews and management reports, 16 original scientific papers and 11 patents. He holds science degrees from the University of Cambridge and Brunel University as well as an MBA from the Open University.