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Gauging the Biosimilar Effect: Will the Market Boom or Bust? Product Image

Gauging the Biosimilar Effect: Will the Market Boom or Bust?

  • Published: January 2012
  • 42 Pages
  • FirstWord Publishing

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 $16.4 billion in sales this year, falling short to just $235 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.

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 READ MORE >

Executive Summary

Biologics
- The Biologics Market
- Patent Landscape
- Innovation comes at a cost

Biosimilars
- Terminology
- Regulatory Overview

The Biosimilars Market
- This is not a generics market
- EU’s biosimilars market
- Biosimilar uptake in the EU
- Initial uptake was rapid in Germany
- Reference Pricing System
- Reimbursement system
- Pre-defined quotas

Market Drivers and Resistors
- Market Drivers
- Cost savings
- Patent expiry
- Fierce competition
- Growth of developing markets
- Expanding uses of drugs
- Market Resistors
- High barriers to entry
- Cost
- Technical challenges
- Clinical challenges
- Lack of substitution and interchangeability
- Substitution
- Interchangeability
- Wholesale switching
- Therapeutic substitution
- Unfavorable biosimilars laws in the US
- Period of market exclusivity
- Data sharing
- Reluctant physicians
- Switching
- Lack of physician and patient education
- Outright opposition to biosimilars
- Lack of incentives
- Patient and public misperception
- Assignment of the International Nonproprietary Name (INN)

Response from innovator companies
- Reduce the price of the innovator drug
- Form a biosimilars division
- Partner with a biosimilars company
- Rely on their resources
- Develop innovative second-generation drugs

Response from biosimilars companies
- Make a capital investment
- Develop competitive marketing strategies
- Early entry strategies
- Direct marketing
- Emerging markets
- Choice of target
- Form partnerships
- Have a legal strategy in place

Market outlook

Summary

Acknowledgements

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