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The Evolving Landscape in Biosimilars

  • March 2015
  • -
  • Datamonitor Healthcare

The outlook for biosimilars has changed dramatically over the last five years, due to product development progress, regulatory guidance, and new company strategies Biosimilars have now moved well past proof of concept, but due to the levels of competition anticipated, only the most suitable will be profitable in the long run This report analyzes the current biosimilars market, how it’s evolved and how it will continue to develop

Features and Benefits:

Determine which strategies will drive success in the evolving biosimilars landscape

Understand the factors that could impact the long-term outlook for biosimilars

Key Questions Answered:

How competitive will the biosimilars market be?

What do industry participants feel are the greatest challenges?

Which are the next big reference products to go after?

Table Of Contents

The Evolving Landscape in Biosimilars
TABLE OF CONTENTS
LIST OF FIGURES
5 EXECUTIVE SUMMARY
5 Analysis headlines and metrics
8 Notes and caveats
10 PAST DEVELOPMENTS
10 What has changed over 2009-14?
17 Bibliography
18 COMPANY STRATEGIES
18 Greater competition in biosimilars expected following major new entrants
20 Strengthening through deals
30 Bibliography
32 PIPELINE PROGRESS
32 Major market Phase III trials triggered by EU pathway implementation
33 Second wave and into the US
36 Sandoz is the leading player in terms of product development
37 Bibliography
38 PROFITABILITY AND CHALLENGES
38 Investment by new entrants means lower returns for all
41 Litigation will impact time to market in many cases
45 Interchangeability remains an unknown
46 Bibliography
48 NEXT TARGET OPPORTUNITIES
48 Biosimilars are dependent upon expiring reference brands
49 Insight from the overall development status of biosimilars
53 Next-wave target reference products
55 Bibliography
56 LONGER-TERM OUTLOOK AND CONSIDERATIONS
56 Near-term drivers and resistors of biosimilars
57 Longer-term factors
59 Bibliography

List of Figures

7 Figure 1: Key summary facts and figures
14 Figure 2: Datamonitor Healthcare's biosimilars survey: views on the overall outlook
15 Figure 3: Datamonitor Healthcare's biosimilars survey: views on expected level of biosimilar
usage in 2020 compared to views five years ago, by respondents
18 Figure 4: Datamonitor Healthcare's biosimilars survey: views on the number of companies in
the biosimilars space in 2014
19 Figure 5: The shift towards major pharmaceutical companies in biosimilars
20 Figure 6: Global deals in biosimilars, 1999-2014
23 Figure 7: Mentions of biosimilars in annual reports across selected major pharmaceutical
companies, 2003-13
24 Figure 8: Mentions of biosimilars in annual reports - Teva, 2003-13
24 Figure 9: Mentions of biosimilars in annual reports - Merck and Co, 2003-13
25 Figure 10: Mentions of biosimilars in annual reports - Pfizer, 2003-13
26 Figure 11: Mentions of biosimilars in annual reports - Biogen Idec, 2003-13
27 Figure 12: Mentions of biosimilars in annual reports - Amgen, 2003-13
28 Figure 13: Mentions of biosimilars in annual reports - Boehringer Ingelheim, 2003-13
32 Figure 14: Major market Phase III clinical trials of biosimilars to 2010
34 Figure 15: Cumulative major market Phase III clinical trials of biosimilars, by molecule type,
2000-15
35 Figure 16: US/EU Phase III biosimilar trial count and FDA biosimilar program metrics
36 Figure 17: Major market Phase III clinical trials of biosimilars, by reference product, 2001-19
37 Figure 18: US/EU Phase III clinical trials of biosimilars, by company and status
38 Figure 19: Datamonitor Healthcare's biosimilars survey: more competition in major markets
40 Figure 20: Price discounts for generics (actual) and biosimilars (estimated)
40 Figure 21: Global adalimumab biosimilars pipeline, by stage and region
42 Figure 22: The role of patent protection and challenges in determining biosimilar launch
timing
44 Figure 23: The impact on biosimilar opportunity of market share loss to next-generation
innovator products
45 Figure 24: Datamonitor Healthcare's biosimilars survey: reduced expectation for
implementation of automatic substitution
48 Figure 25: Expiry dates of US biologic molecule exclusivity periods, 1998-2026
50 Figure 26: Biosimilar development versus reference product peak sales - example guide to the
charts
51 Figure 27: Comparison of biosimilar development status in major markets versus rest of
world/global markets
52 Figure 28: Companies with biosimilars in any stage of major market development versus
clinical stages only
53 Figure 29: Biosimilar opportunities timeline, 1998-2026
56 Figure 30: Datamonitor Healthcare's biosimilars survey: threats and drivers

List of Tables

5 Table 1: Analysis headlines
12 Table 2: Standout events in the biosimilars landscape, 2008-14
21 Table 3: Key major biosimilar market deals, 2008-14
57 Table 4: Longer-term drivers and resistors of biosimilars

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