Can there be abbreviated applications, generics, or follow-on products?

BioPharm International

Volumn 16, Issue 7, 2003, Pages 28-37

  Webster, Christopher ^a   Copmann, Thomas ^a   Garnick, Robert ^a   Green, James ^a   Hayes, Mark ^a   Landis, John ^a   Lubiniecki, Anthony ^a   Murano, Genesio ^a   Seamon, Kenneth ^a   Zezza, Diane ^a   Woollett, Gillian R ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; BETA INTERFERON; BETA1A INTERFERON; CALCITONIN DERIVATIVE; FORCALCITONIN; GENERIC DRUG; GROWTH HORMONE; HEPATITIS B VACCINE; HUMAN GROWTH HORMONE; HUMAN INSULIN; INSULIN; INSULIN GLARGINE; INTERFERON BETA SERINE; RECOMBINANT ALPHA2B INTERFERON; RECOMBINANT BLOOD CLOTTING FACTOR 8; RECOMBINANT HEPATITIS B VACCINE; UNCLASSIFIED DRUG;

BIOEQUIVALENCE; BIOTECHNOLOGY; CHEMICAL STRUCTURE; DATA ANALYSIS; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; DRUG SCREENING; DRUG USE; ENZYME ACTIVITY; IN VIVO STUDY; MOLECULAR WEIGHT; PROPHYLAXIS; REVIEW; SYNTHESIS;

EID: 0037489350     PISSN: 1542166X     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (11)

1. Bende, S., presented at the Hatch-Waxman Update 2002 conference (FDLI, Washington DC, December 2002).
2. "Generic Biologics: Xigris Approval Suggests Precedent for FDA. GPhA Says," FDA Week, p. 32 (16 December 2002).
3. Hatch, O., FDA Week, p. 16 (12 August 2002).
4. "The Drug Price Competition and Patient Term Restoration Act of 1984," U.S. Code Title 35, Section 156 (Hatch-Waxman Act, S-1538, HR-3605, 24 September 1984).
5. "Federal Food, Drug, & Cosmetic Act," U.S. Code Title 21, Section 355(j) (1938, revised 1999).
6. Zoon, K., "CBER Chief: Generic Biologics a Problem from Scientific Standpoint," FDA Week, p. 18 (20 April 2001).
7. McClellan, M., "FDA Generic Biologics Policy May Change Under McClellan," Pink Sheet, p. 7 (14 October 2002).
8. Crawford, L.M., "FDA to Consolidate Review Responsibilities for New Pharmaceutical Products," FDA News (6 September 2002).
9. CDER, Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FDA, Rockville, MD, updated 29 May 2003). Available at www.fda.gov/cder/ob.
10. Copmann, T. et al., "One Product, One Process, One Set of Specifications: A Proven Quality Paradigm for the Safety and Efficacy of Biologic Drugs," BioPharm 14(3), 14-24 (March 2001).
11. ICH, Q6B: Specifications for New Drug Substances and Products: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, CPMP/ICH/365/96 (Geneva, 1999). Also Federal Register 64(159), 44928-44935, Doc. 99-21352 (18 August 1999). BPI