Biosimilars, biogenerics or follow-on biologics

 

Download it for FREE. Click here.

 

Now FREE! Biosimilars, biogenerics and follow-on biologics

 

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.

 

This 50+ -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.

 

Biosimilars: Problems, Prospects and Projections includes coverage of:

 

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


Recent Studies on Biosimilars with Links to Original Documents