THE ROLL OF GENERIC DRUGS– QUALITY AND ECONOMIC ASPECT IN TREATMENT

2016 ◽  
pp. 5-11
Author(s):  
Huu Dung Tran ◽  
Phuoc Bich Ngoc Nguyen
Keyword(s):  
Pharmaceutical Industry ◽  
Generic Drugs ◽  
Pharmaceutical Product ◽  
Economic Aspect ◽  
Assessment Centers ◽  
Expiry Date ◽  
Innovator Product ◽  
Bioequivalence Assessment ◽  
Innovator Company

Generic drugs have an important role in ensuring the efficacy, safety, and especially the economic aspect of drug use. A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product manufactured without a licence from the innovator company and marketed after the expiry date of the patent or other exclusive rights. At present, unlikely FDA’s regulations, Vietnam’s law does not require all generic drugs launching in the market to prove the bioequivalence, the same efficient and safe as innovator drugs. Because of the rapid growth of the domestic pharmaceutical market, the standard and quality of generic drugs compared with innovator drugs have to be consolidated and proved through trials of bioequivalence, then building the faith of professionals and patients in using generic drugs. Thus the expansion of number and improving quality of the bioequivalence assessment centers become an important task of Vietnam pharmaceutical industry in the context of integration with the global pharmaceutical industry. Key words: generic drugs, innovator drugs, patent, bioequivalence, treatment.

scholarly journals “Biosimilar” generic version of biologic products?

2021 ◽  
Vol 2 (2) ◽  
pp. 114-120
Author(s):  
Muhammad Taher ◽  
◽  
Siti Syazwani Shaari ◽  
Deny Susanti ◽  
Keyword(s):  
Generic Version ◽  
Inflammatory Diseases ◽  
Generic Drugs ◽  
Complex Structure ◽  
In Vivo Studies ◽  
Patient Access ◽  
Expiry Date

Biosimilars are currently popular after the expiry date of patents for biological reference products have expired or soon will expire. Besides, this ‘copycat’ version of biologic products offers much lower costs as compared to the reference products, thus promoting better patient access to the treatment of certain diseases such as cancer, inflammatory diseases, skin disorders and diabetes. This review aims to determine the differences between biosimilars and generic drugs and highlight some issues related to biosimilar products such as comparability, interchangeability, immunogenicity, extrapolation of indication, current legislation, pharmacovigilance, and naming system. Scientific sources from PubMed, Google Scholar, ScienceDirect, and Elsevier were accessed for preparation of this review article. Biosimilars are not generic drugs as they have larger and complex structure as compared to the generic drugs. Due to that, biosimilars are highly similar but not identical to the reference products. Many regulatory authorities have authorized biosimilars under a distinct regulatory process from that of the generic drugs and subjected them to comprehensive comparability studies with their reference products (analytical, nonclinical in vitro, and in vivo studies and clinical trials). Additional evidence from interchangeability studies, extrapolation of indication studies, immunogenicity profile assessments, and pharmacovigilance studies are also beneficial to assess the efficacy, safety, and quality of the biosimilar before and/or after receiving their regulatory approval. Biosimilars are different from generic drugs due to their complexity in structure and manufacturing process. More comprehensive studies are required to ensure their benefits is outweigh the risks.

Income and Life Quality of Farmer Households Suffering Social Exclusion

2012 ◽  
pp. 63-87
Author(s):  
Anh Mai Ngoc ◽  
Ha Do Thi Hai ◽  
Huyen Nguyen Thi Ngoc
Keyword(s):  
Labor Market ◽  
Statistical Method ◽  
Social Exclusion ◽  
Central Government ◽  
Life Quality ◽  
Economic Aspect ◽  
Local Authorities ◽  
The Impact

This study uses descriptive statistical method to analyze the income and life qual- ity of 397 farmer households who are suffering social exclusion in an economic aspect out of a total of 725 households surveyed in five Northern provinces of Vietnam in 2010. The farmers’ opinions of the impact of the policies currently prac- ticed by the central government and local authorities to give them access to the labor market are also analyzed in this study to help management officers see how the poli- cies affect the beneficiaries so that they can later make appropriate adjustments.

Current Regulatory Standpoint on Evaluating the Bioequivalence of Different Classes of Generic Drugs - Is the Evaluation in the Right Direction?

2019 ◽  
Vol 20 (10) ◽  
pp. 835-844 ◽  
Author(s):  
Francis Micheal ◽  
Mohanlal Sayana ◽  
Balamurali Musuvathi Motial
Keyword(s):  
Generic Drugs ◽  
Bibliographic Databases ◽  
Eligibility Criteria ◽  
Individual Bioequivalence ◽  
Population Bioequivalence ◽  
Standard Tool ◽  
Review Question ◽  
Guidance Documents ◽  
The Right

Background: The concept of evaluating bioequivalence has changed over a period of time. Currently, the Average Bioequivalence approach (ABE) is the gold standard tool for the evaluation of generics. Of late, many debates had arisen about employing ABE approach for the appraisal of all drug categories. This review aims to examine the limitations of ABE approach and the significances of Population Bioequivalence (PBE) and Individual Bioequivalence (IBE) approach, current regulatory thinking for assessing different categories of the drug, whether they are adequately assessed, and the evaluation is in the right direction. Methods: We carried out an organized search of bibliographic databases for peer-reviewed research literatures, regulatory recommendations, guidance documents using a focused review question and eligibility criteria. The standard tools were used to appraise the quality of retrieved documents and to make sure the authenticity of the data. Results: In total 73 references were used in the review, the majority of the references (guidance documents) were from the different regulatory agencies and product-specific guidance. There were 29 product-specific guidance from USFDA and EMA. The limitations of the ABE approach were discussed in detail along with the significances of Population Bioequivalence (PBE) approach and Individual Bioequivalence (IBE) approaches. Conclusion: It is apparent from the review that IBE approach is a precise method for evaluating the drugs as it answers drug interchangeability (prescribability and switchability). IBE approach is followed by PBE approach and ABE approach for the evaluation of different categories of drugs in terms of precision.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

Pharmacoeconomic features of the use of drugs used in the treatment of allergic rhinitis

2021 ◽  
pp. 9-16
Author(s):  
Afanasyeva T.G. ◽  
Lavrova N.N. ◽  
Tumentseva V.R.
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Nasal Mucosa ◽  
Generic Drugs ◽  
Cost Minimization ◽  
Nasal Congestion ◽  
World Health ◽  
Cost Minimization Analysis ◽  
Wide Range

Rhinitis is an inflammation of the nasal mucosa; today, according to the World Health Organization, the prevalence of the disease is 40% of the world's population. Allergic rhinitis is the most common type of chronic rhinitis, affecting 10–20% of the world's population, and the severity of the disease is associated with a significant deterioration in the quality of life, sleep and performance. Allergic rhinitis is an inflammatory disease of the nasal mucosa caused by exposure to an allergen, causing IgE-mediated inflammation. Clinically, the disease is characterized by the following main symptoms: rhinorrhea, sneezing, itching and nasal congestion. Despite the general symptoms of allergic rhinitis, its impact on the quality of life of patients and the significant cost of treatment, including pharmacotherapy, many patients do not adhere to drug treatment regimens due to their insufficient effectiveness in eliminating the emerging symptoms. Pharmacoeconomic research identifies, measures and compares the costs and effects of drug use. This framework includes research methods related to cost minimization, cost-effectiveness, decision analysis, cost of illness, and patient quality of life. This article will consider one of the four main methods for assessing pharmacoeconomics - cost minimization analysis. A cost-minimization analysis is a pharmacoeconomic assessment by comparing the costs of two or more drug alternatives regardless of outcome. Since the pharmaceutical market is represented by a wide range of original, reference and generic drugs for the treatment of allergic rhinitis, an important aspect of our research is the selection of effective and economically acceptable therapy for outpatients.

scholarly journals Corporate Social Responsibility (CSR) of Innovative Pharmaceutical Corporations. The Case of BIOGEN

2018 ◽  
Vol 21 (3) ◽  
pp. 45-62 ◽  
Author(s):  
Janina Witkowska
Keyword(s):  
Corporate Social Responsibility ◽  
Pharmaceutical Industry ◽  
Social Responsibility ◽  
Corporate Philanthropy ◽  
Developed Countries ◽  
Orphan Drugs ◽  
Pharmaceutical Firms ◽  
Life Saving ◽  
Corporate Social

The aim of this paper is to discuss the common features and specificity of Corporate Social Responsibility (CSR) practices of innovative transnational corporations (TNCs) acting in the pharmaceutical industry. The innovativeness of pharmaceutical firms is understood here as their ability to make a breakthrough in the treatment of rare, incurable diseases. The examination of the issue leads to the conclusion that the specificity of CSR in this industry is related to the contradiction between the economic and social/ethical aspects of innovation processes in this field. A key issue of CSR in the innovative pharmaceutical industry seems to be the pricing of drugs, especially orphan and ultra‑orphan drugs, resulting in patients from less developed countries having limited access to life‑saving medicines or those that improve the quality of life. Corporations use their monopolistic position to set extremely high prices. However, without the market/marketing exclusivity offered to pharmaceutical firms by the law, orphan drugs would probably not be developed, produced and commercialized. Traditional CSR practices (corporate philanthropy, community and neighborhood programs, volunteerism etc.) cannot be treated as sufficient ‘compensation’ for the high prices of medicines. Real, true CSR in the innovative pharmaceutical industry requires either abandoning or reducing extreme monopolistic privileges and offering medicines for rare diseases at lower prices.

scholarly journals A Novel Comparative Evaluation for the Quality of Oral Generic Drugs

2013 ◽  
Vol 39 (3) ◽  
pp. 156-165
Author(s):  
Masato Terashita ◽  
Kazuhiro Iguchi ◽  
Shigeyuki Usui ◽  
Kazuyuki Hirano
Keyword(s):  
Comparative Evaluation ◽  
Generic Drugs

scholarly journals Participation of Kazakhstan Pharmaceutical Companies in Global Value Chains Authors

2021 ◽  
Vol 17 (2) ◽  
pp. 473-485
Author(s):  
Elena D. Frolova ◽  
Zulparuza A. Abdurahkmanova ◽  
Alexander A. Ishukov
Keyword(s):  
Pharmaceutical Industry ◽  
Generic Drugs ◽  
Value Added ◽  
Global Value Chains ◽  
Value Chains ◽  
Pharmaceutical Companies ◽  
Enterprise Level ◽  
Micro Level ◽  
The Republic ◽  
National Economies

Growing interest of national economies in global value chains (GVCs) and the lack of micro-level research brought us to study the integration of countries in GVCs at the enterprise level (using the example of the pharmaceutical industry). We examine the situation in the Republic of Kazakhstan that is beginning to integrate into GVCs. Results of a questionnaire survey of the country’s pharmaceutical companies are considered along with public statistics. We developed a methodology to analyse the participation of a national entity in GVCs at the micro-level (including the enterprise participation in GVCs) and assess the performance of Kazakh pharmaceutical companies. The research is based on export and import data. A hypothesis on the participation of national pharmaceutical enterprises was partially confirmed: several surveyed companies participate in generic drugs GVCs at the production level, thus the value added is low. Features of pioneering entry into pharmaceutical global value chains for countries lacking such integration experience were demonstrated on a specific example. The obtained results can be used by countries starting the process of integration into pharmaceutical GVCs, as well as by Kazakhstan when developing the pharmaceutical industry.

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND REGISTRATION PROCESS OF GENERIC DRUGS IN JAPAN AND CHINA

2018 ◽  
Vol 3 (1) ◽  
pp. 75-87
Author(s):  
Dinesh Chandra Konuri ◽  
Mamillapalli S. ◽  
A. Elphine P. ◽  
Brahma S.R. Desu
Keyword(s):  
Pharmaceutical Industry ◽  
Comparative Study ◽  
Generic Drugs ◽  
Emerging Market ◽  
Generic Product ◽  
Regulatory Requirements ◽  
Registration Process ◽  
Regulated Markets ◽  
Device Agency ◽  
Japan And China

A Generic Product must meet the standards established by Pharmaceutical Medical Device Agency (PMDA) & China Food and Drug Administration (CFDA) to be approved for marketing in Japan and China respectively. This study covers the introduction to generic drugs, and JAPAN & CHINA regulatory authorities. It also includes the requirements and registration of Generic Drugs in above specified countries. It also includes the checklist for comparative study of regulatory requirements and registration process of generic drugs in JAPAN & CHINA. JAPAN and CHINA are two different markets which are important to pharmaceutical industry. Japan is under one of the Regulated markets and owning the world’s second largest pharmaceutical market. Whereas China is under the Emerging market, but unfortunately these two are un trapped markets in the Pharma hub. So, am enthusiastic to know about Regulatory considerations and Registration process of Generic Drugs.

scholarly journals Evaluation of rational prescribing and dispensing of medicines in Mali

2017 ◽  
Author(s):  
Yaya Coulibaly ◽  
Fanta Sangho ◽  
Aboubacar Alassane Oumar
Keyword(s):  
Public Sector ◽  
Private Sector ◽  
Treatment Guidelines ◽  
Generic Drugs ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Medical Practitioners ◽  
The Public ◽  
Quality Of Prescribing

Objective: The drug policy of Mali is based on the concept of essential generic drugs. The adoption of generic drugs in a program is often accompanied by irrational use of these drugs precisely because of the availability of these drugs. Thus, this study was initiated to assess the quality of prescribing and dispensing drugs in Mali. Methods: This is a descriptive cross-sectional study was conducted from 2004 to 2013, the survey was conducted in 20 primary health centers and 20 private pharmacies in three regions of the country. In each of these structures, 30 prescriptions filled at the time of the survey were collected. Results: The average number of drugs per prescription was 3.0 ± 1.3 and 2.4 ± 1.2, respectively, in the public and private sectors. Prescription of drugs under international name was 91.6% in the public sector and 37.2% in the private sector. The public sector prescribed 33.7% of injectable drug against 16.2% in the private sector (p <0.001). The average cost of a prescription was lower in the public sector (3415.3 FCFA or 5.21euros) than in the private sector (7111 FCFA or 10.85 euros).Conclusion: Generic drugs are commonly used in the public, but much less in the private sector. The treatment guidelines are already available, should be introduced interactively to medical practitioners, through visits and intensive supervision by more experienced managers in the hierarchy, it would be likely to improve the quality of prescribing practitioners.

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