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

Date: January 1, 2012
Pages: 42
Price:
US$ 895.00
License [?]:
Publisher: FirstWord
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: G055CA5D6B6EN
Leaflet:

Download PDF Leaflet

Gauging the Biosimilar Effect: will  the Market Boom or Bust?
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.

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
  • Comprehensive and up-to-date overview of the biosimilars market
  • Insight into the resistors and drivers to biosimilar uptake
  • Strategies on how to improve biosimilar spending
  • Discussion of how the branded industry should respond to defend market share
Purchase Reasons

Key Benefits
  • Insight from 16 industry leaders from Europe, the US and Canada
  • Unique insight into the German biosimilars market
  • Recommendations of how the industry can move forward
Key Questions Asked
  • What are the drivers and resistors of biosimilar uptake?
  • Why was Germany the most successful market for biosimilars
  • What strategies should biosimilar manufacturers do to increase uptake
  • How should the branded industry respond?
  • How will the biosimilars industry evolve and what forces will shape it
Who Would Benefit From This Report?
  • Executive Management
  • Sales and Marketing Executives
  • Pricing and Reimbursement Teams
  • Medical and Scientific Affairs Professionals
  • Pharmaceutical Consultants
  • Strategic Planning Executives
  • Clinical Development Professionals
  • Regulatory and Government Affairs Managers
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
  • Gillian Woollett, Vice President, Avalere Health
  • Louis-Christian Clauss, Senior Consultant, Hisut SA and Atheln Biomed
  • Peter Pitts, President and Cofounder, Center for Medicine in the Public Interest
  • Markus Hauser, Director Strategic Commercial Effectiveness, Biogen Idec
  • Alex Kanarek, Senior Consultant, BioProcess Technology Consultants Inc.
  • Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting
  • Andrew Bourgoin, Pharmaceutical Research Analyst, Thomson Reuters
  • Andrew Merron, Director, Biosimilars Advisory Service & Oncology, Decision Resources
  • Ronald Rader, President, Biotechnology Information Institute
  • Steven Grossman, Consultant, Public Policy and FDA
  • Magdalena Leszczyniecka, Founder and CEO, STC Biologics Inc.
  • Kristie Kuhl, Senior Vice President, Makovsky & Co.
  • Clifford Mintz, Management Consultant
  • Dimitrios Papadopoulos, Commercial Executive in the Pharmaceutical Industry
  • Regina Au, Strategic Marketing Consultant, BioMarketing Insight
  • Michael Castagna, Executive Director, Immunoscience Division, Bristol-Myers Squibb
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
Skip to top


Ask Your Question

Gauging the Biosimilar Effect: will the Market Boom or Bust?
Company name*:
Contact person*:
Phone/fax*:
Email*:
Request invoice
Your enquiry:
Please click on a Check Box below to confirm you are not a robot: