The best targets for biogenerics

BioPharm International

Volumn 19, Issue 4, 2006, Pages 50-64

  DiLiberti, Charles E ^a  

^a Barr Laboratories   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCYZYME; APROTININ; BECAPLERMIN; BERACTANT; BLOOD CLOTTING FACTOR 8 CONCENTRATE; BOTULINUM TOXIN A; CALCITONIN; CROFAB; CYCLOSPORIN; CYCLOSPORIN A; DESMOPRESSIN; ENFUVIRTIDE; EPTIFIBATIDE; GLATIRAMER; GLUCAGON; GLUCAGON KIT; GOSERELIN; HIRULOG; HUMAN INSULIN; INSULIN ASPART; INSULIN GLARGINE; INSULIN LISPRO; KREON; LEPIRUDIN; LEUPRORELIN; NESIRITIDE; NEW DRUG; OCTREOTIDE; PAPAIN; PARATHYROID HORMONE[1-34]; PROTEIN; RECOMBINANT GLUCAGON; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; RECOMBINANT HEPATITIS B VACCINE; RECOMBINANT INTERLEUKIN 2; SALCATONIN; SNAKE VENOM ANTISERUM; TRYPSIN; TUBERCULIN; UNINDEXED DRUG; XENADERM;

ARTICLE; DEVICE; DRUG APPROVAL; DRUG CLASSIFICATION; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG PROGRAM; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; HOMEOPATHY; LICENSING;

EID: 33645983353     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

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: www.fda.gov/ohrms/dockets/ dockets/04n0355/04n0355.htm.
14. EMEA Final Guidelines; Available at: www.emea.eu.int/htms/human/ biosimilarfin.htm.