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 Prescription and use of “equivalent” drugs

2007 ◽  
Vol 1 (2) ◽  
pp. 69-87
Author(s):  
Mario Eandi
Keyword(s):  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Generic Drug ◽  
Generic Drugs ◽  
Case Reports ◽  
Branded Drug ◽  
Italian Context

Three case reports, where an “equivalent” drugs is prescribed, are described: a patient treated with lanzoprazole, a man with acute myocardial infarction and a young man with epilepsy. These reports are emblematic of the doubts and problems that doctors have to afford in the choice of a generic drug instead of a branded drug. The Author examines not only clinical, legislative and economical aspects of prescription of generic drugs in the Italian context, but also common questions that patients may ask when a generic drug is prescribed.

Generic Substitution for Psychotropic Drugs

CNS Spectrums ◽  
2009 ◽  
Vol 14 (9) ◽  
pp. 1-7 ◽  
Author(s):  
Pierre Blier
Keyword(s):  
Generic Drug ◽  
Psychotropic Drugs ◽  
Generic Substitution ◽  
Generic Drugs ◽  
Drug Application ◽  
The United States ◽  
Third Party ◽  
Brand Name ◽  
Branded Drug ◽  
United States Food

Most antidepressants and other psychotropics in clinical use are available as generic formulations (Table). The availability of lower-priced, generic drugs can benefit patients and third-party payers, but it should not be assumed that all generic drugs are equally beneficial. There are numerous reports in the literature of unexpected and untoward consequences that occur when a generic drug is substituted for the original brand-name drug. A previously stable clinical response may suddenly deteriorate, or the patient may experience new or more severe adverse events (AEs). The United States Food and Drug Administration requires that manufacturers of generic drugs demonstrate that their formulation has pharmacokinetic properties similar (or bioequivalent) to the brand-name drug. Bioequivalency studies are conducted in healthy volunteers, not in patients who would be treated with that drug. Moreover, bioequivalency studies are conducted on a current lot of the branded drug and do not account for variability between lots of the generic formulation. The manufacturer is only required to submit bioequivalency data that support the Abbreviated New Drug Application (ANDA); the FDA does not require disclosure of failed bioequivalence studies. Unlike brand-name drugs, lengthy and costly clinical studies are not required to show that the generic drug is effective and safe.Although the FDA has taken the position that bioequivalence and therapeutic equivalence are equal, many questions related to the use of generic drugs remain unanswered. The following question-and-answer session is an excerpt of an interview with Pierre Blier, MD, PhD, conducted by Diane Sloan, PharmD, which addresses the issue of generic substitution of psychotropic drugs.

scholarly journals Has the increase in the availability of generic drugs lowered the price of cardiovascular drugs in South Africa?

2016 ◽  
Vol 21 ◽  
pp. 60-66 ◽  
Author(s):  
Varsha Bangalee ◽  
Fatima Suleman
Keyword(s):  
South Africa ◽  
South African ◽  
Generic Drug ◽  
Generic Drugs ◽  
Interquartile Range ◽  
Price Ratio ◽  
Generic Competition ◽  
International Reference ◽  
Drug Prices ◽  
The Relationship

Background: This research focuses on pharmaceutical competition in South Africa where concurrent pricing legislation is being implemented without monitoring the consequences on generic drug competition and usage.Objective: To examine the relationship between originator drug prices and the number of generic brands within the cardiovascular class of drugs and to compare South African prices with international reference prices.Method: Data on private sector drug prices was sourced from the South African Medicine Price Registry. The relationship between the median proportional price and the number of brands in the therapeutic class was analysed using correlation analysis. International reference prices were obtained from the Management Sciences for Health International Drug Price Indicator Guide (2012 edition).Results: A weak correlation between originator and generic drug prices and the number of available brands was observed, the exception being diuretic drugs. The median prices per strength of the originator generic were still higher than the most expensive generic version manufactured by any other company, the exception being telmisartan. Comparison of price ratios between the originator drug, lowest priced generic and international reference price values revealed that the originator drug prices had a median price ratio of 20.99 (interquartile range 7.31—53.46) and the lowest priced generics had a median price ratio of 4.28 (interquartile range 2.10—8.47).Conclusion: Increased generic competition is not a predictor of lower drug prices. The study also concludes that the current South African pharmaceutical policies have not yet achieved the lowest prices for drugs when compared internationally.

GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE

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

Generic Drugs in the Pharmaceutical Market

2016 ◽  
pp. 443-468
Author(s):  
Mercedes Rozano
Keyword(s):  
Generic Drugs ◽  
Pharmaceutical Market ◽  
National Brands ◽  
Product Categories ◽  
Pharmaceutical Expenditures ◽  
Market Shares ◽  
Generic Market ◽  
Packaged Foods ◽  
Generic Products

Over the past three decades, marketing has increased its interest in studying the role of generic products in the pharmaceutical sector, one that has only recently incorporated the concept of “generic” products, compared to others such as the mass market. Since the emergence of generic products as one of national brands' main competitors, these have shown significant growth in both their market share, as well as in new product categories. Initially, the concept of generic products was limited to categories of packaged foods and later extended to categories such as medicine. Pharmaceutical market presents an opportunity to analyze the expansion of the “generic” concept, in a strongly regulated framework. In Europe, different policies have resulted in a varying development of generic market shares. Today, the sustainability of health system is a matter of increasing concern to European governments. Generic drugs offer an opportunity to contain pharmaceutical expenditures, since generic price are lower than their original brand equivalent. Developing this market is the main objective.

Price Comparison between Innovator and Generic Medicines Sold by Community Pharmacies in the State of Penang, Malaysia

2008 ◽  
Vol 6 (1) ◽  
pp. 35-42 ◽  
Author(s):  
Asrul Akmal Shafie ◽  
Mohamed Azmi Hassali
Keyword(s):  
Patent Protection ◽  
Generic Drugs ◽  
The State ◽  
Selling Price ◽  
Generic Medicines ◽  
Cross Sectional ◽  
Foreign Products ◽  
Generic Products ◽  
Collection Form ◽  
The Cost

Generic medicines play a key role in the affordability of pharmaceuticals. This study aims to compare price and to document the actual savings that can be achieved if generics are used by consumers in the state of Penang, Malaysia. This is a cross-sectional pilot study on the price of innovator and generic medicines for the 20 most-used medications in Malaysia. Upon consent, 20 retail pharmacies were conveniently selected. A pre-validated data collection form was used to collect their selling price from the community pharmacist. The analysis was limited to medicines in the same dosage form and dose. Those still under patent protection or combined with other active ingredients were excluded from the study. This study found that most innovator drugs are 27–90 per cent more expensive than generics. Some generic drugs are, however, more expensive than their innovator counterparts (40 per cent higher). Some locally produced generics are also more expensive than foreign products. The current findings suggest that consumers can save up to 90 per cent of the cost of their medication by using generic products. Further investigation is needed to explore the causality of the observed differences in price of products in order to increase their accessibility to the general population.

Generic Drugs—A Look Back and a Look Ahead

1990 ◽  
Vol 3 (3) ◽  
pp. 192-202
Author(s):  
Leon Lachman ◽  
Salvatore Turco ◽  
James T. O'Donnell
Keyword(s):  
Generic Drug ◽  
Generic Drugs ◽  
Drug Industry ◽  
Look Ahead ◽  
Look Back

This review includes the viewpoints of three pharmaceutical scientists tracing the origins of the generic drug industry, examining the recent generic drug controversies, and offering suggestions to hospital practitioners for coping with the controversies.

scholarly journals Generic Drugs Not as Safe as FDA Wants You to Believe

2019 ◽  
Vol 54 (3) ◽  
pp. 283-286 ◽  
Author(s):  
C. Michael White
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
Generic Drugs ◽  
The United States ◽  
Drug Supply ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Time Horizons ◽  
Long Time ◽  
Generic Products

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed.

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