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An Empirical Study on Generic Medicine and Branded Medicine
Abstract
In a person's mind, there are certain myths and misconceptions regarding generic medicines and their uses, safety, and potency, due to the information prevailing in the community. But the actual facts are totally different from that, and this is based on scientific evidence. The purpose of this review is to create awareness and increase knowledge about generic medicine as well as prescribe generic medicine in India. Generic medicine is the same as branded medicine, and it has the same quality, safety, and efficiency as branded medicine. Both medicines undergo rigorous regulatory testing, and after compliance with regulatory requirements, they get approval for marketing. Generic medicines are less costly as compared to branded ones because they do not undergo drug discovery, preclinical studies, advertisements, and so on. Due to this reduction in all processes, billions of dollars are saved, and manufacturing costs are low. Instead, all processes for generic medicine Bioequivalence and bioavailability studies prove that medicines are safe, effective, and as similar as branded products in terms of therapeutic effects and any side effects. To increase generic prescribing and acceptance in India, healthcare professionals have created an awareness program, given knowledge, and promoted generic prescriptions. The prescribing of drugs by a registered medical practitioner with the best utilization of practice and experience according to the disease condition of patients
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Osteoporosis is a debilitating disease characterized by reduced bone mineral density and an increased risk of fractures. This review aims to provide a comprehensive overview of, and map current knowledge, obtained from preclinical and clinical studies of the osteoanabolic agent abaloparatide.
PubMed and Embase were meticulously searched from inception to May 4, 2021.178 titles and abstracts were screened, and 57 full-text articles were assessed for inclusion. A total of 55 articles were included; 5 (9%) in vitro studies, 21 (38%) in vivo studies, and 29 (53%) clinical studies. Preclinical in vitro studies have demonstrated receptor conformation preferability, structural insights into the receptor-agonist complex, and proliferative effects of abaloparatide on osteoblasts. Preclinical studies have shown abaloparatide to be similarly effective to teriparatide using comparable doses in both ambulating mice and rats challenged by disuse. Other animal studies have reported that abaloparatide effectively mitigates or prevents bone loss from ovariectomy, orchiectomy, and glucocorticoids and improves fracture healing. The pivotal clinical study ACTIVE demonstrated 18 months of treatment with abaloparatide substantially increase bone mineral density and reduce fracture risk in post-menopausal women compared with placebo. The extension study ACTIVExtend highlighted that subsequent treatment with alendronate sustained the bone gained by abaloparatide treatment and the reduced fracture risk for up to two years. Post-hoc sub-group analyses have also supported the efficacy and safety of abaloparatide treatment independent of various baseline risk factors. In conclusion, mounting evidence from preclinical and clinical studies has uniformly reported that abaloparatide increases bone mineral density and reduces fracture risk.
The use of generic or branded drug is a great matter of discussion in recent times globally. The government in different countries is also strictly promoting the use of generic drugs in place of branded ones. A generic drug consists of same active ingredient/ingredients as its branded counterpart and found to be equally efficient therapeutically. The cost of generic drugs are much lesser than the branded drugs as they do not need to go through the robust and costly pre-clinical or clinical studies as done in branded ones which increases the cost of them up to many folds. The present review enlightens the effectiveness of generic drugs as compared to branded drugs and how they work in body. An attempt is also made to highlight the cost comparison between both classes, the regulations and control pertaining to generic and branded drugs.
A generic drug is more efficient, safe and low-cost alternative of the innovator or branded drug in the market. They are similar to the branded drugs in strength, quality, purity and their safety and efficacy have been proven since they have been in the market for a longer time. The availability of generic medicine should be made easier throughout the world. The US has one of the most demanding regulatory authorities and registration of drug products will be a long process if not complied with the US Food and Drug Administration (USFDA) guidelines. Abbreviated New Drug Application is the application to be filed for registering generic drug. One of the main tasks of the regulatory authorities is to ensure that the drug development, manufacture and testing has been carried out according to the regulations and guidelines and that everything is documented accordingly. International Conference on Harmonization (ICH) established a harmonized format for submission of application on registering drug products. This paper approaches the registration requirements of generic drugs in the form a dossier for market authorization in the US. © 2018, Association of Pharmaceutical Teachers of India. All rights reserved.
This article provides a brief overview of the processes of drug discovery and development. Our aim is to help scientists whose research may be relevant to drug discovery and/or development to frame their research report in a way that appropriately places their findings within the drug discovery and development process and thereby support effective translation of preclinical research to humans. One overall theme of our article is that the process is sufficiently long, complex, and expensive so that many biological targets must be considered for every new medicine eventually approved for clinical use and new research tools may be needed to investigate each new target. Studies that contribute to solving any of the many scientific and operational issues involved in the development process can improve the efficiency of the process. An awareness of these issues allows the early implementation of measures to increase the opportunity for success. As editors of the journal, we encourage submission of research reports that provide data relevant to the issues presented.
Background
The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. The FDA, however, has limited mechanisms to encourage generic drug manufacturing. Main resultsGeneric drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics. Conclusions
We present here a focused review describing the influences on generic manufacturers who are prioritizing drugs for generic development. We also review proposed strategies that regulators may use to incentivize generic drug development.
A generic drug is a product that is comparable to brand/reference listed drug product in dosage form, potency, route of administration, quality and intended use. Generic drugs are equal and within the acceptable bioequivalence range to the brand name drugs. Branded drugs are typically sold at elevated prices as a large substantial human intervention is applied from inception to commercialization. For taking approval of generics, ANDA (Abbreviated New Drug Application) is filed. An approval of generic drug product requires rigorous standards established by the drug authority with respect to identity, strength, quality, purity, and potency. However, some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass-produced, very small variations in purity, size, strength, and other parameters are permitted.
Keywords: ANDA, ICH, NDA
Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient/consumer perspectives of generic medicines.
Literature published between January 2003 and November 2014, which is indexed in PubMed and Scopus, on the topic of opinions of physicians, pharmacists and patients with respect to generic medicines was searched, and articles within the scope of this review were appraised. Search keywords used included perception, opinion, attitude and view, along with keywords specific to each cohort.
Following review of titles and abstracts to identify publications relevant to the scope, 16 papers on physician opinions, 11 papers on pharmacist opinions and 31 papers on patient/consumer opinions were included in this review. Quantitative studies (n = 37) were the most common approach adopted by researchers, generally in the form of self-administered questionnaires/surveys. Qualitative methodologies (n = 15) were also reported, albeit in fewer cases. In all three cohorts, opinions of generic medicines have improved but some mistrust remains, most particularly in the patient group where there appears to be a strongly held belief that less expensive equals lower quality. Acceptance of generics appears to be higher in consumers with higher levels of education while patients from lower socioeconomic demographic groups, hence generally having lower levels of education, tend to have greater mistrust of generics.
A key factor in improving confidence in generic products is the provision of information and education, particularly in the areas of equivalency, regulation and dispelling myths about generic medicines (such as the belief that they are counterfeits). Further, as patient trust in their physician often overrules their personal mistrust of generic medicines, enhancing the opinions of physicians regarding generics may have particular importance in strategies to promote usage and acceptance of generic medicines in the future.
Our aim
was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Health for each country was extracted. Additionally, key informant interviews were performed for validation. Of the 21 countries selected, approximately half provided an official country-level definition for generic pharmaceuticals. The others did not have any definition or referred to the WHO. Only two-thirds of the countries had specific requirements for generic pharmaceuticals, often associated with clinical interchangeability. Most countries with requirements mention bioequivalence, but few required bioavailability studies explicitly. Over 30 % of the countries had other terms associated with generics in their definitions and processes. In countries with generic drug policies, there is reference to patent and/or data protection during the drug registration process. Several countries do not mention good manufacturing practices as part of the evaluation process. Countries in Africa and Eastern Mediterranean regions appear to have a less developed regulatory framework. In summary, there is significant variability in the definition and classification of generic drugs in emerging markets. Standardization of the definitions is necessary to make international comparisons viable.
Background: Same drug can be sold for different prices under different brand names due to various reasons. Branded medicine is the original product that has been developed by a pharmaceutical company and generic medicine is a copy of the original branded product, marketed after the expiry date of the patent and hence supposed to be of low cost as compared to their branded versions. The objective was
to compare the costs of various branded and generic medicine and to ascertain the rationality of emphasizing generic versus branded prescription.
Methods: Prices of 50 commonly used branded and generic medicines available as both branded and generic forms and in same concentration, dosage form and combination were selected and the percentage difference in the mean cost of generic and branded medicines was calculated.
Results: The mean cost of 26 generic medicines out of the selected 50 medicines was higher than their branded versions. Mean cost of 20 branded medicines was higher than generic ones, and cost of 4 medicines was approximately same. Percentage difference in the mean costs of branded and generic medicines varied from <10%
to >70%.
Conclusions: Most of the drugs available in the market have brand names whether
they are branded or generic medicines. Hence, doctor should write a cheapest known
brand with the name of the generic salt in bracket so that the patient can buy another
if that brand is not available. Furthermore, the Drug Controller of India should release
a website where every doctor should be able to find the cheapest and approved drugs
in the market.
The regulatory requirements of various countries of the world vary from each other. Therefore, it is challenging for the companies to develop a single drug which can be simultaneously submitted in all the countries for approval. The regulatory strategy for product development is essentially to be established before commencement of developmental work in order to avoid major surprises after submission of the application. The role of the regulatory authorities is to ensure the quality, safety, and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution, and promotion of it. One of the primary challenges for regulatory authority is to ensure that the pharmaceutical products are developed as per the regulatory requirement of that country. This process involves the assessment of critical parameters during product development.
Generic medicines are those where patent protection has expired, and which may be produced by manufacturers other than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. Our objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and legislative level, from originator medicines. We describe the current and historical regulation of medicines in the world's two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics and their originator equivalents including the reasons for the cost differences seen between originator and generic medicines. Ireland is currently poised to introduce generic substitution and reference pricing. This article refers to this situation as an exemplar of a national system on the cusp of significant health policy change, and specifically details Ireland's history with usage of generic medicines and how the proposed changes could affect healthcare provision.
In the Current scenario, different countries have to follow different regulatory requirements for marketing authorization application (MAA) approval of new drug. In this present work, we studied the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organisation (CDSCO).
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two drugs are bioequivalent it means that they would be expected to be, for all intents and purposes, the same. In determining bioequivalence between two drugs such as a reference drug (Brand) and potential to be test drug (marketed generic drug), pharmacokinetic studies are conducted whereby, each of the drugs are administered in a cross over study to volunteers subjects (healthy individuals). Serum/plasma are obtained at regular intervals and assayed for parent drug (metabolites) concentration. Blood concentration levels are neither feasible or possible to compare the two drugs, then pharmacodynamic endpoints rather than pharmacokinetic end points are used for comparison. For a pharmacokinetic comparison, the plasma concentration data are used to assess key pharmacokinetic parameters such as area under the curve (AUC), peak concentration (Cmax), time to peak concentration (Tmax), and absorption lag time (tlag). Testing should be conducted at several different doses, especially when the drug displays non-linear pharmacokinetics. If 90% Confidence interval for the ratio of the geometric least square means of natural log transformed Cmax, AUC0-t and AUC0-inf of Test and Reference drugs are within 80.00% to 125.00%, then bioequivalence will be establish.
Pharmaceutical Regulatory Affairs (PRA) is a vital unit in a pharmaceutical company that successfully drives the Research and Development (R&D) efforts of the company to the market. Various government agencies are involved in regulating drugs within their market, namely, USFDA-US, EDQM-Europe, TGA-Australia, MHRA-UK and TPD-Canada. A regulatory affair is becoming increasingly influential in the overall drug development process and is increasingly populated by highly trained scientists and medical professionals. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of drugs. This article will focus the similarities and differences in drug approval process of Europe, USA & Indian regulatory bodies. Years ago, a regulatory affair was often just a place where paperwork was done. There is still a lot of paperwork, although much of it is now in electronic format, but science and strategy now take precedence. So this paper point up the comparative regulatory approval process & requirements of the documents/CTD specifications to the drug regulatory authorities in the Europe, USA and India.
Communication about prescription drugs ought to be a paragon of public science communication. Unfortunately, it is not. Consumers see $4 billion of direct-to-consumer advertising annually, which typically fails to present data about how well drugs work. The professional label-the Food and Drug Administration's (FDA) mechanism to get physicians information needed for appropriate prescribing-may also fail to present benefit data. FDA labeling guidance, in fact, suggests that industry omit benefit data for new drugs in an existing class and for drugs approved on the basis of unfamiliar outcomes (such as depression rating scales). The medical literature is also problematic: there is selective reporting of favorable trials, favorable outcomes within trials, and "spinning" unfavorable results to maximize benefit and minimize harm. In contrast, publicly available FDA reviews always include the phase 3 trial data on benefit and harm, which are the basis of drug approval. However, these reviews are practically inaccessible: lengthy, poorly organized, and weakly summarized. To improve accessibility, we developed the Drug Facts Box: a one-page summary of benefit and harm data for each indication of a drug. A series of studies-including national randomized trials-demonstrates that most consumers understand the Drug Facts Box and that it improves decision-making. Despite calls from their own Risk Communication Advisory Committee and Congress (in the Affordable Care Act) to consider implementing boxes, the FDA announced it needs at least 3-5 y more to make a decision. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information.
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