The Best Targets for Biogenerics - - BioPharm International

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The Best Targets for Biogenerics


BioPharm International
Volume 19, Issue 4

ACKNOWLEDGEMENTS

The author wishes to express his gratitude to Mr. Nicholas Tantillo and Ms. Christine Mundkur for their invaluable assistance and regulatory guidance.

Charles E. DiLiberti is vice president of scientific affairs at Barr Laboratories,Inc., 400 Chestnut Ridge Road,Woodcliff Lake, NJ,07677,

REFERENCES

1. Webber K. Scientific considerations related to developing follow-on protein products. FDA Public Workshop; 2004 Sept. 14-15; Rockville, MD

2. The Food Drug and Cosmetics Act. 1938 June 25.

3. The Food, Drug, and Cosmetics Act, 21 USC 321(g)(1) Definition of drug.

4. The Food, Drug and Cosmetic Act Section 505(b)(1).

5. The Food, Drug and Cosmetic Act Section 505(b)(2).

6. The Food, Drug and Cosmetic Act Section 505(j).

7. Public Health Service Act. Title 42 United States Code. Chapter 6.

8. Food and Drug Administration Modernization Act of 1997.

9. US Code. Title 42, Chapter 6A, Subchapter II, Part F. Subpart 1. Regulation of biological products. 42 USC 262(i).

10. Code of Federal Regulations. Title 21—Food and Drugs. Chapter I Subchapter F — Biologics. Part 600 – Biological Products: General. 21 CFR 600.3(h).

11. IMS Health National Sales Perspective Audit, IMS Health, Fairfield, CT.

12. FDA, CDER, Office of Pharmaceutical Science, Office of Generic Drugs. Approved drug products with therapeutic equivalence evaluations. Known as the Orange Book.

13. FDA Public Docket 2004N-0355; Available at: http://www.fda.gov/ohrms/dockets/dockets/04n0355/04n0355.htm.

14. EMEA Final Guidelines; Available at: http://www.emea.eu.int/htms/human/biosimilarfin.htm.


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