04P-0171
C 5
Volume 1

Comment

Exhibit 1 - Excerpt from Combating Generics: Pharmaceutical Brand Defense Online Report Summary, Cutting Edge Information (2004), available at http://www.pharmagenerics.com/ (Copyrighted Material)

Exhibit 2 - Excerpt from Generic Biologics: The Next Frontier, ABN AMRO Inc., June 2001, available at
http://www.cptech.org/ip/health/biotech/genbio062001.pdf (Copyrighted Material)

Exhibit 3 - Statement of Mathias Hukkelhoven, Ph.D. Novartis Pharmaceuticals Corporation, FDA Public Workshop Scientific Considerations Related to Developing Follow-On Protein-Products Sept. 14-15, 2004

Exhibit 4 - Regulation of Biologics Manufacturing: Questioning the Premise, G. E. Gamerman, 49 Food & Drug. L.J. 213 (1994) (Copyrighted Material)