Biosimilars

Problems, Prospects and Projections

Product Code VOI00005
Publication Date April 2009
Publisher VOI Consulting
Product Type Report
Pages 57
ISBN Number not applicable
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Biosimilars

Problems, Prospects and Projections

Biosimilars, biogenerics or follow-on biologics - by any name, second generation versions of blockbuster biologic products are coming to America and they are going to have a profound impact on all aspects of the pharmaceutical industry. Now, VOI Consulting, publisher of PharmaHandbook and GenericHandbook, is offering Biosimilars: Problems, Prospects and Projections, a single-source analysis of this fast-moving topic, for immediate download. For only $337, this 55-page PDF report, written in April 2009, provides current information on the economic, manufacturing, regulatory, legislative, competitive and marketing issues that make biosimilars such a lucrative but challenging opportunity. Although focused on the U.S., the report also examines developments in Japan, Canada, Australia, India and China. Experiences in the European Union, which has the most advanced biosimilar sector, are given special attention. An appendix provides summaries and links to a dozen recent economic, scientific and commercial studies on the subject. Biosimilars are already changing business models and bringing in a whole new set of competitors. Download Biosimilars: Problems, Prospects and Projections today and get out in front of what is certain to be one of the industry-transforming issues of the coming decade.

Contents

  • The Need and Opportunity
    • Biologics losing patent protection
  • Terminology
  • Legal and Regulatory Background
    • Definition of ""Biologics""
    • PHS Act
  • Intellectual Property Considerations
  • Economics of Biosimilars
    • Cost of Entry
  • Marketing Considerations
  • Manufacturing Issues
  • Qualifying sameness
  • Need for additional trials
  • Substitution and Incentives for Use
  • Omnitrope Approval
  • Potential Generic Lovenox
  • Other Countries
    • Australia
    • Japan
    • Canada
  • European Regulatory Framework
    • EU Approval Patterns
    • Companies
    • Member State Substitution Policies
    • Market experiences
  • U.S. Path Forward
  • Data Exclusivity: the Latest Major Stumbling Block
    • Naming
    • Legislative Initiatives
    • Likely outcomes
  • Market Experience: Current and Future
    • Companies in the Biogeneric Segment
    • The Bio-better Model