scholarly journals Original drugs and their generics: a problem of choice

2009 ◽  
Vol 15 (2) ◽  
pp. 209-213
Author(s):  
S. Y. Martsevich ◽  
S. Tolpygina
Keyword(s):  
Comparative Studies ◽  
Generic Drugs ◽  
Therapeutic Equivalence ◽  
Generic Medicines ◽  
Enalapril Maleate

The main distinctions of original and generic drugs are described, and the registration criteria of generics are given. The article considers the main causes of bioequivalence and therapeutic equivalence mismatch of original and generic medicines presenting several examples based on the results of clinical comparative studies, including Enalapril Maleate (comparison of original Renitec and generic Enam). The main approaches of planning the therapeutic equivalence comparative studies are offered.

scholarly journals Comparative studies of the kinetics of dissolution of medicines on the basis of clopidogrel

2021 ◽  
pp. 26-34
Author(s):  
O. P. Baula ◽  
O. O. Saliy ◽  
V. I. Bessаrabov ◽  
A. М. Gerasimchuk
Keyword(s):  
Comparative Studies ◽  
Generic Drugs ◽  
Dissolution Kinetics ◽  
Dissolution Test ◽  
Generic Medicines ◽  
Dissolution Medium ◽  
Clopidogrel Bisulfate ◽  
Kinetics Of Dissolution ◽  
Kinetics Of

Generic medicines occupy dominant positions both in the pharmaceutical market of Ukraine and in industrial production by domestic pharmaceutical enterprises. The use of generic drugs in medical practice is of significant medical and social importance for expanding the accessibility of the general population to essential drugs. In Ukraine, more than twenty generic medicines based on clopidogrel, both foreign and domestic, are registered. All generic drugs containing clopidogrel bisulfate must comply with pharmaceutical bisulfate must comply with pharmaceutical equivalence, the kinetics of release of the active pharmaceutical ingredient using the Dissolution test in vitro, and pharmacokinetic parameters in vivo. The aim of the work was to carry out comparative studies of the dissolution kinetics of four samples of generic drugs based on clopidogrel with the dissolution kinetics of the original drug Plavix®, to evaluate the similarity factor of dissolution profiles and to determine the effect of biopharmaceutical factors on the equivalence of generics. Comparative studies of the kinetics of dissolution were carried out by the in vitro method according to the «Dissolution» test using a device with a blade with a rotation speed of 50 rpm, a dissolution medium with a pH value of 2.0 in a volume of 900 ml at a temperature of 37 ± 1 °C. The determination of the quantitative content of clopidogrel, which passed into the dissolution medium, was carried out by the method of adsorption spectrophotometry in the ultraviolet region at a wavelength of about 240 ± 2 nm. Based on the data obtained, the dissolution profiles of the original drug Plavix® and the studied samples of generic drugs were constructed, the similarity of which was assessed by the value of the similarity factor. According to the research results, it was found that one sample of the generic drug proved its equivalence by the in vitro method to Plavix®, and three other samples of generics had differences in dissolution kinetics in comparison with the original drug. Biopharmaceutical factors were analyzed that could affect the dissolution kinetics of the studied generic drugs, from which the physicochemical characteristics of clopidogrel bisulfate, the qualitative and quantitative composition of excipients and the features of the technological process were determined. Thus, on the basis of the comparative studies of the dissolution kinetics of drugs based on clopidogrel, generics were found that did not correspond to the in vitro equivalence according to the Dissolution test to the original drug, which could be due to the influence of a combination of biopharmaceutical factors.

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.

scholarly journals Physicians’ Knowledge, Attitude and Practice of Generic Substitution in China: A Cross-Sectional Online Survey

2021 ◽  
Vol 18 (15) ◽  
pp. 7749
Author(s):  
Mingyue Zhao ◽  
Lingyi Zhang ◽  
Zhitong Feng ◽  
Yu Fang
Keyword(s):  
Online Survey ◽  
Generic Substitution ◽  
Generic Drugs ◽  
Final Analysis ◽  
Generic Medicine ◽  
Generic Medicines ◽  
Online Questionnaire ◽  
Cross Sectional ◽  
Ordered Logistic Regression ◽  
Tertiary Hospitals

The purpose of this study is to investigate physicians’ knowledge, attitudes and practice of generic medicine substitutions in China. We conducted a cross-sectional online questionnaire survey on physicians from secondary or tertiary hospitals in China from 2020 December to 2021 April. Descriptive statistical and ordered logistic regression were used for analysis. A total of 1225 physicians were included in the final analysis, and only 330 (26.94%) of them scored 4 or above in the knowledge part, which means that the physicians have a good knowledge of generic substitutions. Of the total, 586 (47.83%) agreed or strongly agreed that generic drugs could be substituted for originator drugs and 585 (47.75%) always or often prescribed generic medicines. The percentage of physicians with a positive attitude toward or that practice prescribing generic medicine is below 50%, which needs to be improved in China. Physicians’ knowledge, their attitude toward generic substitution, if familiar with the policy of generic substitution, and incentives for prescribing generic medicines are influencing factors for the practice of generic substitution. Our studies show that the practice of generic substitution by physicians could be improved by several measures in China. We suggested that the physicians should be taught more about the bulk-buy policy and the generic-originator equivalence evaluation policy. Moreover, government incentives to promote generic substitution should be established. Our study also suggested that physicians with less working experience and female physicians should learn more about generic substitution.

GENERIC DRUGS AND THERAPEUTIC EQUIVALENCE

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

General Perception Regarding The Generic and Branded Medicines among the Visitors of the Turaif General Hospital

2021 ◽  
Vol 15 (12) ◽  
pp. 3516-3518
Author(s):  
Nawaf Alotaibi
Keyword(s):  
Saudi Arabia ◽  
General Hospital ◽  
Health Care Professionals ◽  
Generic Drugs ◽  
Generic Medicine ◽  
Cross Sectional Study ◽  
Generic Medicines ◽  
Kingdom Of Saudi Arabia ◽  
Cross Sectional ◽  
Awareness Programs

Background: The utilization of generic drugs in Saudi Arabia is under development. Many studies concerning generic drugs and their utilization by the consumers and promotion by health care professionals have been conducted in Saudi Arabia. Most of these studies revealed general unawareness of generic medicines among the Saudi people. Objective: The objective of this study was to evaluate the general perception regarding the generic medicines and branded medicines among the visitors of the Turaif general hospital. Methods: This cross‑sectional study was carried out from December 29, 2019, to January 23, 2020, at Turaif General Hospital, Turaif, Kingdom of Saudi Arabia using a questionnaire. The questionnaire was shared with the visitors (N = 527) of the hospital after their agreement, and the data were collected. The obtained data were statistically analyzed by Statistical Product and Service Solutions (SPSS) version 16. Results: The results of this study revealed that more than 50% of the participants were unaware about generic medicines and branded medicines; preferred imported generic medicines over local generics; agreed that the imported generic medicines are of high quality, more effective, and expensive as well. However, almost 50% of the participants were not sure about the quality, efficacy, safety, price, and side effects of the branded medicine. Conclusion: It has been concluded that there is a need to provide awareness programs about branded medicine, imported generic medicine, and locally manufactured generic medicines. Keywords: Branded drugs, Generic drugs, Awareness, Turaif, Saudi Arabia.

Corporate Social Responsibility of Pharmaceutical Industry Towards Access to Medicine

2019 ◽  
pp. 793-832
Author(s):  
Rakhi Rashmi
Keyword(s):  
Corporate Social Responsibility ◽  
Social Responsibility ◽  
Patent Protection ◽  
Generic Drugs ◽  
World Health Organisation ◽  
Access To Medicines ◽  
World Health ◽  
Generic Medicines ◽  
Drug Manufacturing ◽  
Corporate Social

India has changed its patent policy in 2005. It was compliance to WTO TRIPs provision and after this there was prohibition on process or generic manufacturing. India is the biggest supplier of affordable generic medicines and this patent protection is said to be beneficial to novel drug manufacturing countries. The generic drugs can be a differentiation factor between lives starting point and the ending point for millions of people in developing countries. This remains an obstacle to inexpensive generic medicines which results in devastating impact on the poorer people. These patent laws allow large MNC's to place ‘profits over people'. World Health Organisation report price of medicines are important for maintaining the affordability and access of the medicines. This research evaluates the strategies and practices of Glaxo Smith Kline in contribution towards the access to medicines and their contribution of corporate social responsibility in India.

Knowledge and perception differences towards generic medicines consumption among consumers

2019 ◽  
Vol 16 (1) ◽  
pp. 19-26
Author(s):  
Mohd Redhuan Dzulkipli ◽  
Siti Noorsuriani Maon ◽  
Mohamed Azmi Hassali
Keyword(s):  
Generic Drugs ◽  
Generic Medicine ◽  
Generic Medicines ◽  
Public And Private ◽  
Good Level ◽  
Significant Difference ◽  
Level Of Knowledge ◽  
Klang Valley ◽  
The Government ◽  
Amount Of Knowledge

The objective of this study was to evaluate the population behavioural influence towards generic medicines use in a Klang Valley. A self-administered questionnaire in the Klang Valley, Malaysia, was distributed conveniently. A total of 222 respondents have participated in the study (response rate 57.8%). The majority of the respondents (87.7%) have reported considerable amount of knowledge on the generic medicine availability in the market. In comparison of sociodemographic influence, only household size was found to influence the respondent’s knowledge and curiosity. For the perception, there was a statistically significant difference in attitude scores for respondents who had good level of knowledge (M = 3.322, SD = 0.516) and poor level of knowledge (M = 3.011, SD = 0.591) towards generic medicines; t(220) = –4.180, p < 0.05. In terms of subjective norms, data findings indicate a statistically significant difference in scores for respondents who had good level of knowledge (M = 3.456, SD = 0.704) and poor level of knowledge (M = 3.057, SD = 0.616) towards generic medicines; t(220) = –4.393, p < 0.05. Similarly, this study found a statistically significant difference in perceived behavioural control scores for respondents who had good level of knowledge (M = 3.605, SD = 0.548) and poor level of knowledge (M = 3.121, SD = 0.577) towards generic medicines; t(220) = –6.350, p < 0.05. Therefore, these results reveal that good level of knowledge really influence the level of perceptions among consumers of generic medicines. It is imperative that more initiatives to be introduced by the government to promote the practice to prescribe generic drugs to the population. The need to educate both health professionals and patients on the availability of the cheaper and bioequivalence medicine should be put into formality, thus increasing the awareness of the patient of the generic medicine and next reduce the dependency of the costlier innovator brand medicine in the prescription at both public and private healthcare settings.

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.

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 Knowledge, attitude and practices regarding generic medicines and its usage: a community-based study

2019 ◽  
Vol 6 (5) ◽  
pp. 2182 ◽  
Author(s):  
Kirthinath Ballala ◽  
Chythra R. Rao ◽  
Aparna S. Chaudhary ◽  
Ashwini S. Bidnurmath ◽  
Akhilesh K. Pandey
Keyword(s):  
Urban Areas ◽  
Generic Drugs ◽  
Community Outreach ◽  
Essential Medicines ◽  
Generic Medicines ◽  
Online Questionnaire ◽  
Community Based ◽  
Cross Sectional ◽  
Total Study Population ◽  
The Government

Background: India is the largest provider of generic medications globally. Despite this, several essential medicines remain inaccessible to majority of the general population, due to poor awareness, unavailability of drugs, distrust about the quality of the medicines, poor policy implementation and inadequate recommendation by doctors.Methods: A community-based cross-sectional study was carried out among 1151 adults in rural and urban areas attached to the community outreach area of a University Medical College. Written informed consent was taken from the participants. Data was collected using a pre-tested semi-structured online questionnaire and analysed using SPSS 15.0.Results: Knowledge regarding generic medicines was found to be low among the surveyed population (666, 57.9%), irrespective of their socio-economic status, education, occupation, place of residence or presence of chronic illnesses. As the knowledge was poor, participants were briefed about the generic medicines and their benefits. Thereafter, the attitude was assessed and found to be favourable among more than half (633, 55.0%) of the surveyed population. The usage of Generic medicines was found to be poor among the respondents. Only 53 (4.6%) of the total study population had switched from branded to generic medicines in the past six months as generic medicines were less expensive compared to their branded counterparts.Conclusions: The awareness about generic drugs and its usage was poor in the surveyed population. A favourable attitude towards generic drugs was achieved by educating the people about their similarity to branded medications. Therefore, there is a need to educate people not only about the quality, safety and efficacy of the generic medicines but also about the government initiatives like the Jan Aushadhi scheme. 

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