GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE

JAMA ◽  
1968 ◽  
Vol 206 (8) ◽  
pp. 1785 ◽  
Author(s):  
Dale G. Friend
Keyword(s):  
Generic Drugs ◽  
Therapeutic Equivalence

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 Correlation of reference and generic fluconazole-based drugs

2020 ◽  
pp. 98-104
Author(s):  
A. S. Dukhanin
Keyword(s):  
Generic Drugs ◽  
Medical Community ◽  
Quantitative Composition ◽  
Therapeutic Equivalence ◽  
Efficacy And Safety ◽  
Federal Law ◽  
Reference Drug ◽  
State Register ◽  
The Law ◽  
Preclinical And Clinical Studies

The article describes the basic rules for the selection of a systemic antifungal drug from the fluconazole-based preparations available on the Russian pharmaceutical market. Questions of interchangeability of generic and original drugs, research of equivalence (pharmaceutical, pharmacokinetic), possible methodological difficulties of its estimation are discussed. Data on comparative analysis of original and generic fluconazole drugs are presented. The algorithm of rational choice of a drug on an example of fluconazole is formulated, property of a drug to suppress selectively activity of fungi of genus Candida, not showing hepatotoxic drugs, and also questions of correlation between reference and generic drugs on the basis of fluconazole is considered. The Federal Law “On Amendments to the Federal Law “On Circulation of Medicines“ No. 429-FZ (adopted on December 22, 2014 and entered into force on July 1, 2015) regarding the establishment of the procedure for determining the interchangeability of drugs, states: “Information on the interchangeability of drugs shall be included in the State Register of Medicines from January 1, 2018“. The law discloses the notion of interchangeable drugs, which “means a drug with proven therapeutic equivalence or bioequivalence regarding reference drugs, having equivalent qualitative formula and quantitative composition of active substances, formula and method of administration“. However, some definitions used so far in the law have been changed. Thus, instead of the term “original medicine“ the term “reference drug“ is used from July 1, 2015, which is defined as a medicine first registered in the Russian Federation, the quality, efficacy and safety of which has been proved based on the results of preclinical and clinical studies, and which is used to assess the bioequivalence or therapeutic equivalence, quality, efficacy and safety of generic or bioanalogue medicine. However, this article still uses the terms “original“ and “generic“ drugs, which are familiar to our medical community.

scholarly journals Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

Drugs ◽  
2018 ◽  
Vol 78 (4) ◽  
pp. 523-524
Author(s):  
Joshua J. Gagne ◽  
Jennifer M. Polinski ◽  
Wenlei Jiang ◽  
Sarah K. Dutcher ◽  
Jing Xie ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Therapeutic Equivalence

Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

Drugs ◽  
2017 ◽  
Vol 77 (4) ◽  
pp. 427-433 ◽  
Author(s):  
Joshua J. Gagne ◽  
Jennifer M. Polinski ◽  
Wenlei Jiang ◽  
Sarah K. Dutcher ◽  
Jing Xie ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Therapeutic Equivalence

Generic drugs: benefit/risk ratio

2021 ◽  
Vol 13 (6) ◽  
pp. 98-104
Author(s):  
E. A. Ushkalova ◽  
S. K. Zyryanov ◽  
I. A. Gopienko
Keyword(s):  
Clinical Practice ◽  
Active Ingredient ◽  
Comparative Studies ◽  
Generic Drugs ◽  
Comparable Efficacy ◽  
Synthesis Methods ◽  
Therapeutic Equivalence ◽  
Efficacy And Safety ◽  
Attending Physician ◽  
The Impact

The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice. Results of pharmacoepidemiological studies, which have been widely carried out recently, speak of insufficient understanding of the impact of generics on remote outcomes of chronic diseases, including mortality. The longterm economic prospects of generic drug administration continue to remain unclear. Among the primary differences between generics and brandname drugs are the differences in active ingredient synthesis methods and the composition of adjuvants and additives. Comparative studies on the therapeutic equivalence of generics with their originals or between themselves are rarely conducted. They are often affected by methodological flaws, which cannot ensure their comparable efficacy and safety. In this regard, automatic replacement of drugs containing the same active ingredient should be avoided without the participation of the attending physician.

Generics in Latin America: Trends and Regulation

2008 ◽  
Vol 6 (1) ◽  
pp. 43-56 ◽  
Author(s):  
Claudia Patricia Vacca González ◽  
James F. Fitzgerald ◽  
Joan Rovira
Keyword(s):  
Latin American ◽  
Generic Drugs ◽  
Therapeutic Equivalence ◽  
The Public ◽  
Pharmaceutical Markets ◽  
Incipient Stage ◽  
Incentive Policies ◽  
Innovative Drugs ◽  
Regulatory Trends ◽  
Latin American And Caribbean

The purpose of this study was to establish regulatory trends related to competing drugs in several Latin American and Caribbean countries and to review regulations and national policies on generic drugs in these countries. Furthermore, information on the incentives to register and produce competing drugs, the promotion of international non-proprietary name (INN) use, the regulation of bioequivalence studies and the substitution of drugs prescribed by lower price alternatives to the public was also obtained. The results showed three regulatory categories: those countries that favour financing of competing drugs and the extended promotion of INN use, without restricting the substitution of innovative drugs with competitors; those that have a scheme oriented to the demonstration of the therapeutic equivalence, that is, countries that restrict the substitution of the original drugs to some authorised competing drugs; and those that are in an incipient stage of their regulation process. This variety causes difficulties in the characterisation of the pharmaceutical markets and can generate fictitious segmentations. In conclusion, harmonisation efforts should take into account the possible relationship among the definitions adopted by the countries, the national pharmaceutical markets development and their incentive policies for competition.

Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence

2016 ◽  
Vol 25 (8) ◽  
pp. 944-952 ◽  
Author(s):  
Joshua J. Gagne ◽  
Jennifer M. Polinski ◽  
Wenlei Jiang ◽  
Sarah K. Dutcher ◽  
Jing Xie ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Therapeutic Equivalence

scholarly journals To the question about rational choice between original and generic drugs: arguments to use the first

2019 ◽  
Vol 12 (2) ◽  
pp. 106-111
Author(s):  
N. S. Khodzhaev ◽  
A. V. Starostina
Keyword(s):  
Rational Choice ◽  
Generic Drugs ◽  
Physical Characteristics ◽  
Eye Drops ◽  
Therapeutic Equivalence ◽  
Safety And Efficacy

Issues of safety and efficacy of drugs attracts much attention worldwide. The growing use of generics and the lack of stringent requirements to research focused on their biological and therapeutic equivalence are causing concern of ophthalmologists. The literary review presents hypotensive properties and physical characteristics of the major original and generic hypotensive eye drops.

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