Generic Drug Products and Therapeutic Equivalence

2013 ◽  
pp. 1753-1757
Keyword(s):  
Generic Drug ◽  
Therapeutic Equivalence ◽  
Drug Products

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

scholarly journals Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

BMJ ◽  
2018 ◽  
pp. k1180 ◽  
Author(s):  
Rishi J Desai ◽  
Ameet Sarpatwari ◽  
Sara Dejene ◽  
Nazleen F Khan ◽  
Joyce Lii ◽  
...  
Keyword(s):  
Cohort Study ◽  
Generic Drug ◽  
Drug Products

A Practical Guide to Drug Product Selection: Getting to Know the Food and Drug Administration's (FDA's) Approved Drug Products List (Orange Book) With Therapeutic Equivalence Evaluations

1995 ◽  
Vol 8 (3) ◽  
pp. 115-120
Author(s):  
David L. Rosen
Keyword(s):  
Health Professionals ◽  
Drug Product ◽  
Therapeutic Equivalence ◽  
Product Selection ◽  
Drug Products ◽  
Practical Guide ◽  
Orange Book

This article provides pharmacists and other health professionals with a practical guide to using FDA's Orange Book, the authoritative source for FDA approved products and their respective therapeutic equivalence ratings. Copyright © 1995 by W.B. Saunders Company

scholarly journals Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

2021 ◽  
Vol 09 (10) ◽  
pp. 23-39
Author(s):  
Md. Imtiaz Hasan ◽  
Shahnaz Akter Shimu ◽  
Akhi Akther ◽  
Ishrat Jahan ◽  
Md. Hamiduzzaman ◽  
...  
Keyword(s):  
Generic Drug ◽  
Drug Products ◽  
Regulatory Aspects ◽  
Pharmaceutical Industries
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