Generic Drugs

2002 ◽  
Author(s):  
Keyword(s):  
Generic Drugs

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.

Cost-minimization analysis of drugs used in the treatment of Asthma and COPD diseases in India

2020 ◽  
Vol 15 ◽  
Author(s):  
Billu Payal ◽  
Anoop Kumar ◽  
Harsh Saxena
Keyword(s):  
Generic Drugs ◽  
Cost Minimization ◽  
Cost Savings ◽  
Chronic Obstructive ◽  
Pulmonary Medicine ◽  
Potential Cost ◽  
Maximum Cost ◽  
Cost Minimization Analysis ◽  
Cost Variation ◽  
The Cost

Background: Asthma and Chronic Obstructive Pulmonary Diseases (COPD) are well known respiratory diseases affecting millions of peoples in India. In the market, various branded generics, as well as generic drugs, are available for their treatment and how much cost will be saved by utilizing generic medicine is still unclear among physicians. Thus, the main aim of the current investigation was to perform cost-minimization analysis of generic versus branded generic (high and low expensive) drugs and branded generic (high expensive) versus branded generic (least expensive) used in the Department of Pulmonary Medicine of Era Medical University, Lucknow for the treatment of asthma and COPD. Methodology: The current index of medical stores (CIMS) was referred for the cost of branded drugs whereas the cost of generic drugs was taken from Jan Aushadi scheme of India 2016. The percentage of cost variation particularly to Asthma and COPD regimens on substituting available generic drugs was calculated using standard formula and costs were presented in Indian Rupees (as of 2019). Results: The maximum cost variation was found between the respules budesonide high expensive branded generic versus least expensive branded generic drugs and generic versus high expensive branded generic. In combination, the maximum cost variation was observed in the montelukast and levocetirizine combination. Conclusion: In conclusion, this study inferred that substituting generic antiasthmatics and COPD drugs can bring potential cost savings in patients.

Indian Pharmaceutical Industries Current Status and Togetherness to Overcome Speed Breakers in Term of Quality Issues to Make India as a Global Pharma Destination

2020 ◽  
Vol 07 ◽  
Author(s):  
Vikas Rathee ◽  
Kapil Pihwal ◽  
Neelam Pawar ◽  
Sheikh Aamir ◽  
Mohammad Shahbaz Alam ◽  
...  
Keyword(s):  
Generic Drugs ◽  
Regulatory Compliance ◽  
Pharmaceutical Products ◽  
Current Status ◽  
Family Welfare ◽  
United States Dollar ◽  
Doing Business ◽  
Pharmaceutical Industries ◽  
Governmental Control ◽  
Future Plans

: Regulatory is the heart of the Pharmaceutical Industries which acts as an interface between the industries and government authorities for the growth and development of pharmaceutical industry system of their respective country. In 2017, India was a pharmaceutical country valued at USD (United States Dollar) 13 billion and accounting for 20 percent of worldwide exports, making the country the main supplier of generic drugs worldwide. Ministry of Chemicals and Fertilizers, the Department of Pharmaceutical Products said that the national pharmaceutical market's gross revenue reached approximately US $ 18.12 billion in 2018 (Rs 129,015), growing 9.4% year-on-year and export retention in 2018 was US $ 17.88 billion. 19.14 billion US$ in 2019. The Union Ministry of Health and Family Welfare has increased by 13.1 percent to Rs 61,398 crore (US $ 8.98 billion) in the Union Budget 2019-20. The Indian pharmaceutical market is facing many difficulties such as central and state regulatory compliance, data integrity, ethics committee in clinical trials, governmental control over the price of medicine, lack of research and so on. We are discussing in our article that top 10 pharmaceutical companies are doing business, their turnover in 2020 and challenge in today's era. We discuss future plans and solutions to problems, so that they can be ranked first in the world.

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.

Patents, Patent Trolls and Intellectual Property

2017 ◽  
Author(s):  
David Segal
Keyword(s):  
Intellectual Property ◽  
Generic Drugs ◽  
Patent Documents

Chapter 11 gives an outline of intellectual property, in particular patents. The structure of patent documents is described. The use of patents literature as a source of technical conformation is stressed. The significance of non-practicing entities or patent trolls in lawsuits is highlighted. The effect on the sale of generic drugs when a patent lapses is discussed.

scholarly journals BIOSIMILARS IN INFLAMMATORY BOWEL DISEASES: an important moment for Brazilian gastroenterologists

2015 ◽  
Vol 52 (1) ◽  
pp. 76-80 ◽  
Author(s):  
Fábio Vieira TEIXEIRA ◽  
Paulo Gustavo KOTZE ◽  
Aderson Omar Mourão Cintra DAMIÃO ◽  
Sender Jankiel MISZPUTEN
Keyword(s):  
Small Molecules ◽  
Inflammatory Bowel Diseases ◽  
Generic Drugs ◽  
Specific Data ◽  
Chemical Structures ◽  
Bowel Diseases ◽  
Original Product ◽  
Inflammatory Bowel ◽  
The One ◽  
Extrapolation Of Indications

ABSTRACT Biosimilars are not generic drugs. These are more complex medications than small molecules, with identical chemical structures of monoclonal antibodies that lost their patency over time. Besides identical to the original product at the end, the process of achieving its final forms differs from the one used in the reference products. These differences in the formulation process can alter final outcomes such as safety and efficacy of the drugs. Recently, a biosimilar of Infliximab was approved in some countries, even to the management of inflammatory bowel diseases. However, this decision was based on studies performed in rheumatologic conditions such as rheumatoid arthritis and ankylosing spondylitis. Extrapolation of the indications from rheumatologic conditions was done for Crohn’s disease and ulcerative colitis based on these studies. In this article, the authors explain possible different mechanisms in the pathogenesis between rheumatologic conditions and inflammatory bowel diseases, that can lead to different actions of the medications in different diseases. The authors also alert the gastroenterological community for the problem of extrapolation of indications, and explain in full details the reasons for being care with the use of biosimilars in inflammatory bowel diseases without specific data from trials performed in this scenario.

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.

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