Gauging the Biosimilar Effect: will the market boom or bust?

Introduction

Introduction

It was supposed to be the “epoch of biosimilars”, or drugs that copied existing biologics but had the potential to be more cost-effective. Yet five years later, biosimilars have failed to reach their forecasted potential of .4 billion in sales this year, falling short to just 5 million in 2010.

The pitfalls—everything from cost and unfavorable US legislation to a lack of interchangeability and physician resistance—have led some in the industry to ring the death knell. Yet according to others, the market remains alluring, predominantly because it represents life-changing medicine and the future of healthcare.

Scope

Report Overview

Cast against European and particularly German experiences, Gauging the Biosimilar Effect: will the market boom or bust? looks at the current state-of-play for biosimilars. The report, based on 16 industry interviews, examines the drivers and resistors to the still-unproven biosimilars market. The report moves from a general discussion of biosimilars to an explanation why they proved immediately popular in Germany. Market drivers—patent expiry, developing markets and costs savings—are reflected against the roadblocks, including high barriers to entry, lack of substitution, repressive US legislation and the physicians’ reluctance to engage. Finally, the report reviews the responses of both innovator and biosimilar companies, as well as their strategies for future success.

Highlights

Key Report Features

Puchase Reasons

Key Benefits

Key Questions Asked

Who Would Benefit From This Report?

Key quotes

“I think that the biosimilar market will become a part of the landscape where major pharmaceutical companies and biotechnology companies will control that market, and use the biosimilar market as a means to extend the lifecycle of their innovative franchises.”

– Clifford Mintz, Management Consultant

“In the US and other countries where there is much more importance placed on price, and where the private sector insurers are a lot more involved, and where government is now seeking to reduce drug spending, yes, price could very well be the number one determinant of gaining market share for biosimilars in the US market.”

– Ronald Rader, President of the Biotechnology Information Institute

“Unless you have 100% patient interchangeability, you don’t have 100% medication interchangeability. You have acceptable ranges. But an acceptable range for a generic statin is one thing. An acceptable interchangeability rate for rheumatoid arthritis is something else entirely.”

– Peter Pitts, President and Cofounder, Center for Medicine in the Public Interest

Expert Views

Table of Contents
for Gauging the Biosimilar Effect: will the market boom or bust?

• 1.Executive Summary

  2.Biologics

  2.1. The Biologics Market

  2.2. Patent Landscape

  2.3. Innovation comes at a cost

  3.Biosimilars

  3.1. Terminology

  3.2. Regulatory Overview

  4.The Biosimilars Market

  4.1. This is not a generics market

  4.2. EU’s biosimilars market

  4.3. Biosimilar uptake in the EU

  4.4. Initial uptake was rapid in Germany

  4.5. Reference Pricing System

  4.6. Reimbursement system

  4.7. Pre-defined quotas

  5.Market Drivers and Resistors

  5.1. Market Drivers

  5.2. Cost savings

  5.3. Patent expiry

  5.4. Fierce competition

  5.5. Growth of developing markets

  5.6. Expanding uses of drugs

  5.7. Market Resistors

  5.8. High barriers to entry

  5.9. Cost

  5.10. Technical challenges

  5.11. Clinical challenges

  5.12. Lack of substitution and interchangeability

  5.13. Substitution

  5.14. Interchangeability

  5.15. Wholesale switching

  5.16. Therapeutic substitution

  5.17. Unfavorable biosimilars laws in the US

  5.18. Period of market exclusivity

  5.19. Data sharing

  5.10. Reluctant physicians

  5.20. Switching

  5.21. Lack of physician and patient education

  5.22. Outright opposition to biosimilars

  5.23. Lack of incentives

  5.24. Patient and public misperception

  5.25. Assignment of the International Nonproprietary Name (INN)

  6. Response from innovator companies

  6.1. Reduce the price of the innovator drug

  6.2. Form a biosimilars division

  6.3. Partner with a biosimilars company

  6.4. Rely on their resources

  6.5. Develop innovative second-generation drugs

  7. Response from biosimilars companies

  7.1. Make a capital investment

  7.2. Develop competitive marketing strategies

  7.3. Early entry strategies

  7.4. Direct marketing

  7.5. Emerging markets

  7.6. Choice of target

  7.7. Form partnerships

  7.8. Have a legal strategy in place

  8.Market outlook

  9.Summary

  10.Acknowledgements

Additional Details

Publisher

FirstWord Pharma

Publisher Information

Reference

1 |

Number of Pages

42

Report Format

PDF

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