Background Information Sources
Some useful information resources include:
Biopharmaceutical Products in the U.S. and European Markets
, the only inforamtion resource/reference
(database/Web site) concerning marketed biopharmaceutical products, concentrating on
products' biotechnology and commercial aspects; An absolute necessity for anyone interested in
biosimilars, with this the only published and useful source for much needed reference
- Follow-on Biologics - Biotechnology Industry Organization's Web page/site
Biogenerics Generic Pharmaceutical Association (GPhA) Web page/site
- Alliance for Safe Biologic Medicines
- Biosimilars -
European Federation of Pharmaceutical Industries and Associations (EFPIA); links to European Union guidelines and concept papers.
- FDA Views on Follow-on Proteins: Statement by Dr. J. Woodcock, FDA, to the the Committee on Oversight and Government Reform, House of Representatives, 3/26/2007. FDA explains prior biogeneric-like (abbreviated) biopharmaceutical approvals in The FDA's assessment of follow-on protein products: a historical perspective (for a copy of the full copyrighted article, try the FDA public affairs office).
Trade Commission's (FTC) Roundtable on Follow-on Biologics: Framework for Competition and Continued Innovation transcripts from a Nov. 2008 conference.
- The Competitive Implications of Generic Biologics, by a Commissioner, Federal Trade Commission (FTC); includes comments on the basic differences between drug and biologics (generic vs. innovator) approaches to new regulations
- Generic Biologics: The Next Frontier, by
ABN Amro, June 2001. Old, but still a good overview.
Exploring the Pathway to Generic Biologics: Are Therapeutically Equivalent Biologics Feasible and Desirable?, National Organization for Rare Disorders (white paper from March 2003 conference).
- Biologics: Can There Be Abbreviated Applications,
Generics, or Follow-On Products?, BioPharm International, July 1, 2003, presents views associated with PhRMA and its members
- EMEA/EU Guideline on Similar Biological Medicinal Products, 12/2004; and four concept papers concerning biosimilar products: insulin;
Also, see the News page, which cites some additional publications, mostly