Pub Date : 2022-06-12DOI: 10.1177/17411343221107569
Georges Hatem, N. Navasardyan, Elsa Lahoud, S. Awada, Rana Itani, R. Ajrouche, Mathijs Goossens
The use of generic medicines facilitate access to treatment and reduce the overall health cost. Policies promoting generic substitution take into account many components such as quality and efficacy considering health stakeholders including physicians and pharmacists and identifying factors impacting generics prescription. The current study aimed to assess the association between the perception of physicians towards generics with their sex and age and their willingness to switch to generics after initial treatment. Furthermore, it aimed to evaluate the predictors for switching brands to generics after initial treatment and perceiving the exclusivity to perform this substitution. Prescription of generics to lower medical cost was more common among younger physicians compared to those 50 years and older. Interestingly, physicians aged 40 and above were more prone to prescribe generics to patients without medical coverage, while compared to physicians younger than 30 years of age. Age was significantly associated with switching initial treatment to generics, which was 2.46 times higher for physicians older than 50 years compared to those younger than 30 years. In addition, physicians practicing more than 20 years were about 1,5 times more accepting the substitution by pharmacists after initial treatment by brand while compared to physicians practicing for less than 10 years. Strategies to increase generic substitution and promoting its acceptance among physicians should take into consideration the different significant predictors. However, Further research is required to explore more factors, predicting prescription of generics in Lebanon, such as visits by medical representatives, regulations of the hospital that the physician is practicing, which are also proven to have high influence on the prescription practice of generics.
{"title":"Predictors of substitution to generic drugs and physicians’ perceived exclusivity of substitution: A cross sectional survey among physicians","authors":"Georges Hatem, N. Navasardyan, Elsa Lahoud, S. Awada, Rana Itani, R. Ajrouche, Mathijs Goossens","doi":"10.1177/17411343221107569","DOIUrl":"https://doi.org/10.1177/17411343221107569","url":null,"abstract":"The use of generic medicines facilitate access to treatment and reduce the overall health cost. Policies promoting generic substitution take into account many components such as quality and efficacy considering health stakeholders including physicians and pharmacists and identifying factors impacting generics prescription. The current study aimed to assess the association between the perception of physicians towards generics with their sex and age and their willingness to switch to generics after initial treatment. Furthermore, it aimed to evaluate the predictors for switching brands to generics after initial treatment and perceiving the exclusivity to perform this substitution. Prescription of generics to lower medical cost was more common among younger physicians compared to those 50 years and older. Interestingly, physicians aged 40 and above were more prone to prescribe generics to patients without medical coverage, while compared to physicians younger than 30 years of age. Age was significantly associated with switching initial treatment to generics, which was 2.46 times higher for physicians older than 50 years compared to those younger than 30 years. In addition, physicians practicing more than 20 years were about 1,5 times more accepting the substitution by pharmacists after initial treatment by brand while compared to physicians practicing for less than 10 years. Strategies to increase generic substitution and promoting its acceptance among physicians should take into consideration the different significant predictors. However, Further research is required to explore more factors, predicting prescription of generics in Lebanon, such as visits by medical representatives, regulations of the hospital that the physician is practicing, which are also proven to have high influence on the prescription practice of generics.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"10 1","pages":"23 - 32"},"PeriodicalIF":0.0,"publicationDate":"2022-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72981351","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-30DOI: 10.1177/17411343221097243
Stephen M. Roylance
{"title":"US Legal and Regulatory Update","authors":"Stephen M. Roylance","doi":"10.1177/17411343221097243","DOIUrl":"https://doi.org/10.1177/17411343221097243","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"13 1","pages":"126 - 129"},"PeriodicalIF":0.0,"publicationDate":"2022-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82350238","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-21DOI: 10.1177/17411343221097251
R. Milchior, S. Charbonnel
Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor: Richard Milchior and Séverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008 Paris France Tel: +33 (0)1 53 43 15 15 Fax: +33 (0) 1 53 43 15 00 Email Email: s.charbonnel@herald-avocats.com
{"title":"PHARMACEUTICAL; TRADEMARK; PATENTS; NEWS","authors":"R. Milchior, S. Charbonnel","doi":"10.1177/17411343221097251","DOIUrl":"https://doi.org/10.1177/17411343221097251","url":null,"abstract":"Compiled and written by SCP Herald Herald Avocats is a French law firm involved in intellectual property law, pharmaceutical law and European Union law that provides services to healthcare, biotech and pharmaceutical companies. This section is intended to be a synopsis of recent developments and is not intended to be all comprehensive. If any (issue) information referred to in this section is to be relied upon, specific advice should be sought. Please contact the Editor: Richard Milchior and Séverine Charbonnel SCP Herald 91 rue du Faubourg Saint Honore 75008 Paris France Tel: +33 (0)1 53 43 15 15 Fax: +33 (0) 1 53 43 15 00 Email Email: s.charbonnel@herald-avocats.com","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"47 1","pages":"116 - 125"},"PeriodicalIF":0.0,"publicationDate":"2022-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91060275","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-05-08DOI: 10.1177/17411343221098791
B. Tempest
The fall in ANDA generic medicines approvals in the USA that was seen in 2020 has continued into 2021. West Virginia University has bought a 23-acre generic medicines manufacturing plant in the USA which employed 1400 workers for $1 from Viatris. The Indian generic companies ranked first with 42% of all USA ANDA approvals and the Chinese companies came in third with 10%. [Extracted from the article] Copyright of Journal of Generic Medicines is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
从2020年开始，美国ANDA仿制药批准数量下降的趋势将持续到2021年。西弗吉尼亚大学在美国以1美元的价格从Viatris购买了一个23英亩的仿制药生产厂，雇佣了1400名工人。印度仿制药公司以42%的份额排名第一，中国公司以10%的份额排名第三。[摘自文章]《Journal of Generic Medicines》的版权是Sage Publications Inc.的财产，未经版权所有者的明确书面许可，其内容不得复制或通过电子邮件发送到多个网站或发布到listserv。但是，用户可以打印、下载或通过电子邮件发送文章供个人使用。这可以删节。对副本的准确性不作任何保证。用户应参阅原始出版版本的材料的完整。(版权适用于所有人。)
{"title":"Journal of Generic Medicine – Editorial June 2022","authors":"B. Tempest","doi":"10.1177/17411343221098791","DOIUrl":"https://doi.org/10.1177/17411343221098791","url":null,"abstract":"The fall in ANDA generic medicines approvals in the USA that was seen in 2020 has continued into 2021. West Virginia University has bought a 23-acre generic medicines manufacturing plant in the USA which employed 1400 workers for $1 from Viatris. The Indian generic companies ranked first with 42% of all USA ANDA approvals and the Chinese companies came in third with 10%. [Extracted from the article] Copyright of Journal of Generic Medicines is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"4 1","pages":"71 - 71"},"PeriodicalIF":0.0,"publicationDate":"2022-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79492301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-22DOI: 10.1177/17411343221091182
Waad O Mahmoud Soliman, A. Shehata, R. Mosallam
Background: International Nonproprietary Names (INN) is prescribing the name of the active ingredient. Objective: This study aimed to investigate INN prescription rates and perceived barriers towards INN prescribing at a public Ministry of Health and Population (MOHP) hospital specialized in treating infectious diseases in Egypt. Methods: A retrospective chart review was conducted in a 280-bed specialized Ministry of Health Hospital in Alexandria, Egypt. Medications were described either as brand or generic based on WHO Essential Medicines List (EML) classification system and the Egyptian National Formulary. All physicians with prescribing authority in study hospital were administered a questionnaire composed of two sections. The first section explored the socio-demographic and work characteristics of the physicians, and the second section listed the barriers towards INN prescription. Results: Out of the 400 medical records reviewed, 2279 drugs were prescribed. About half of the medications (52.61%) were prescribed in INN. The medicines which were most frequently prescribed in INN were electrolytes solution (99.5%), laxatives (98.6%), and vitamins and minerals (85.2%) and coagulation medicines (82%). Other medications were exclusively prescribed in brand names as antispasmodics, antidiarrheal, dermatology and vascular insufficiency medications. Only 38.75% were trained using INNs to designate medications, about half of physicians (48%) reported that they rarely use INNs in their practice. The most frequently listed reasons for not prescribing in INN prescribing perceived by physicians were physicians being not familiar with INN (79.0%), doubts about the efficacy, safety, or quality of generic drugs (52.0%) and absence of educational programs regarding INN use (47.0%). Conclusion and Relevance: The current study illustrates only half of the prescriptions are prescribed using INN. A multifaceted approach using explicit policy for obligating INN prescription, together with educational sessions for physicians about the value of INN prescription and the bioequivalence of generic medications to their brand counterparts.
{"title":"International Nonproprietary Names prescription in a specialized public hospital in Egypt","authors":"Waad O Mahmoud Soliman, A. Shehata, R. Mosallam","doi":"10.1177/17411343221091182","DOIUrl":"https://doi.org/10.1177/17411343221091182","url":null,"abstract":"Background: International Nonproprietary Names (INN) is prescribing the name of the active ingredient. Objective: This study aimed to investigate INN prescription rates and perceived barriers towards INN prescribing at a public Ministry of Health and Population (MOHP) hospital specialized in treating infectious diseases in Egypt. Methods: A retrospective chart review was conducted in a 280-bed specialized Ministry of Health Hospital in Alexandria, Egypt. Medications were described either as brand or generic based on WHO Essential Medicines List (EML) classification system and the Egyptian National Formulary. All physicians with prescribing authority in study hospital were administered a questionnaire composed of two sections. The first section explored the socio-demographic and work characteristics of the physicians, and the second section listed the barriers towards INN prescription. Results: Out of the 400 medical records reviewed, 2279 drugs were prescribed. About half of the medications (52.61%) were prescribed in INN. The medicines which were most frequently prescribed in INN were electrolytes solution (99.5%), laxatives (98.6%), and vitamins and minerals (85.2%) and coagulation medicines (82%). Other medications were exclusively prescribed in brand names as antispasmodics, antidiarrheal, dermatology and vascular insufficiency medications. Only 38.75% were trained using INNs to designate medications, about half of physicians (48%) reported that they rarely use INNs in their practice. The most frequently listed reasons for not prescribing in INN prescribing perceived by physicians were physicians being not familiar with INN (79.0%), doubts about the efficacy, safety, or quality of generic drugs (52.0%) and absence of educational programs regarding INN use (47.0%). Conclusion and Relevance: The current study illustrates only half of the prescriptions are prescribed using INN. A multifaceted approach using explicit policy for obligating INN prescription, together with educational sessions for physicians about the value of INN prescription and the bioequivalence of generic medications to their brand counterparts.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"12 1","pages":"223 - 232"},"PeriodicalIF":0.0,"publicationDate":"2022-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81493820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-04-12DOI: 10.1177/17411343221081719
R. Milchior, S. Charbonnel
{"title":"European union legal and regulatory update","authors":"R. Milchior, S. Charbonnel","doi":"10.1177/17411343221081719","DOIUrl":"https://doi.org/10.1177/17411343221081719","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80799823","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-26DOI: 10.1177/17411343221076744
Atefeh Mousavi, Marjan Monadizadeh, M. Mohammadzadeh
Objective Product life cycle (PLC) refers to the time ranging from when a product is introduced into the market until it is taken off the shelves. Product life cycle management can guarantee product survival and prevent it from declining. The purpose of this study is to explore factors influencing the life cycle of generic pharmaceutical product and their effect sizes to shed light on better approaches for the life cycle management of such products. Method To this end, a standard questionnaire containing six dimensions and 47 items was used to collect data from 302 industrial pharmacists. The research hypotheses were tested using structural equation modeling to quantify the relationship between each dimension and its associated factors with the PLC. Key finding The results indicated that government interventions (Standard estimate (SE) = 0.63) and technology advancement (SE = 0.60) as environmental factors, quality (SE = 0.60) and price (SE = 0.62) satisfaction, patient adherence (SE = 0.68), physicians' awareness (SE = 0.64), market saturation (SE = 0.60); and demand rate (SE = 0.62) as demand factors, brand power (SE = 0.92); and availability of imported competitors (SE = 0.59) as competition factors, drug safety (SE = 0.63), product appearance (SE = 0.57); and ease of administration (SE = 0.61) as product-related factors, manufacturer reputation (SE = 0.63); and production continuity (SE = 0.64) as producer-related factors, and distributors number (SE = 0.54); and on-time delivery and availability of products (SE = 0.69) as distributor-related factors at 5% significance levels had the most effect on generic pharmaceutical PLC in Iran. Conclusion For the first time, this study offers a structural equation modeling framework for better managing the PLC of generic pharmaceutical products to help the company’s performance and survival.
{"title":"Developing a structural equation model for the life cycle of generic pharmaceutical products","authors":"Atefeh Mousavi, Marjan Monadizadeh, M. Mohammadzadeh","doi":"10.1177/17411343221076744","DOIUrl":"https://doi.org/10.1177/17411343221076744","url":null,"abstract":"Objective Product life cycle (PLC) refers to the time ranging from when a product is introduced into the market until it is taken off the shelves. Product life cycle management can guarantee product survival and prevent it from declining. The purpose of this study is to explore factors influencing the life cycle of generic pharmaceutical product and their effect sizes to shed light on better approaches for the life cycle management of such products. Method To this end, a standard questionnaire containing six dimensions and 47 items was used to collect data from 302 industrial pharmacists. The research hypotheses were tested using structural equation modeling to quantify the relationship between each dimension and its associated factors with the PLC. Key finding The results indicated that government interventions (Standard estimate (SE) = 0.63) and technology advancement (SE = 0.60) as environmental factors, quality (SE = 0.60) and price (SE = 0.62) satisfaction, patient adherence (SE = 0.68), physicians' awareness (SE = 0.64), market saturation (SE = 0.60); and demand rate (SE = 0.62) as demand factors, brand power (SE = 0.92); and availability of imported competitors (SE = 0.59) as competition factors, drug safety (SE = 0.63), product appearance (SE = 0.57); and ease of administration (SE = 0.61) as product-related factors, manufacturer reputation (SE = 0.63); and production continuity (SE = 0.64) as producer-related factors, and distributors number (SE = 0.54); and on-time delivery and availability of products (SE = 0.69) as distributor-related factors at 5% significance levels had the most effect on generic pharmaceutical PLC in Iran. Conclusion For the first time, this study offers a structural equation modeling framework for better managing the PLC of generic pharmaceutical products to help the company’s performance and survival.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"11 1","pages":"176 - 186"},"PeriodicalIF":0.0,"publicationDate":"2022-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87232153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-24DOI: 10.1177/17411343221076963
Georges Hatem, Elsa Lahoud, Leyan Halwani, Farah Mcheik, D. Khachman, S. Awada
INTRODUCTION: The unified medical prescription was implemented as a policy to decrease the overall health expenditures and increase the use of generic drugs. The main objective of this study was to evaluate the perception of Lebanese physicians towards the unified medical Prescription and its impact on the overall generic prescription. Additionally, an overview was assessed concerning the type of drugs that physicians tend more to accept to be substituted to generic alternatives. METHODS: A cross-sectional descriptive study was conducted in Lebanon over a period of three months targeting physicians in their private clinics or in various hospitals using a survey as an instrument. RESULTS: Our findings demonstrated that more than the half of respondents (56.6%) believed that the unified medical prescription preserves the exclusivity for physicians to choose the medication while only 39.5% of physicians think that the unified medical prescription encouraged generic prescription and almost 42% admitted that the unified medical prescription lowers the medical cost for the patient. DISCUSSION: Despite that this new medical form of prescription is a high achievement for the Lebanese Ministry Of Public Health, this last should make essential actions: coordinating the generic drug substitution policy and monitoring its implementation over time and achievement of goals; establishing appropriate pricing system and medicines prices and controlling the interactions between physicians, pharmacists, and pharmaceutical industries; ensure their full commitment; and update the national list of substitutable generic drugs. CONCLUSION: The main objective of the unified medical prescription is to decrease the pharmaceutical expenditure and to provide access to medications for patients with lower socio-economic status. Lebanese physicians reported that this tool did not achieve its goal yet but have an impact on lowering the medical cost for patients and promoting generic prescription.
{"title":"The unified medical prescription as a tool to promote generic prescription: A cross-sectional study addressing physicians’ perception in Lebanon","authors":"Georges Hatem, Elsa Lahoud, Leyan Halwani, Farah Mcheik, D. Khachman, S. Awada","doi":"10.1177/17411343221076963","DOIUrl":"https://doi.org/10.1177/17411343221076963","url":null,"abstract":"INTRODUCTION: The unified medical prescription was implemented as a policy to decrease the overall health expenditures and increase the use of generic drugs. The main objective of this study was to evaluate the perception of Lebanese physicians towards the unified medical Prescription and its impact on the overall generic prescription. Additionally, an overview was assessed concerning the type of drugs that physicians tend more to accept to be substituted to generic alternatives. METHODS: A cross-sectional descriptive study was conducted in Lebanon over a period of three months targeting physicians in their private clinics or in various hospitals using a survey as an instrument. RESULTS: Our findings demonstrated that more than the half of respondents (56.6%) believed that the unified medical prescription preserves the exclusivity for physicians to choose the medication while only 39.5% of physicians think that the unified medical prescription encouraged generic prescription and almost 42% admitted that the unified medical prescription lowers the medical cost for the patient. DISCUSSION: Despite that this new medical form of prescription is a high achievement for the Lebanese Ministry Of Public Health, this last should make essential actions: coordinating the generic drug substitution policy and monitoring its implementation over time and achievement of goals; establishing appropriate pricing system and medicines prices and controlling the interactions between physicians, pharmacists, and pharmaceutical industries; ensure their full commitment; and update the national list of substitutable generic drugs. CONCLUSION: The main objective of the unified medical prescription is to decrease the pharmaceutical expenditure and to provide access to medications for patients with lower socio-economic status. Lebanese physicians reported that this tool did not achieve its goal yet but have an impact on lowering the medical cost for patients and promoting generic prescription.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"4 1","pages":"214 - 222"},"PeriodicalIF":0.0,"publicationDate":"2022-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86469472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-23DOI: 10.1177/17411343221076371
E. Yordanov, I. Parvova, E. Hristov, V. Petkova
Aim: The objective is to study the availability and affordability of biosimilar medicinal products containing monoclonal antibodies, measure their drug utilization, and evaluate the rational drug use globally through analysis and systematic review of scientific articles published in the scientific literature. Materials and methods: The documentary analysis of scientific publications was carried out by specific keywords in MEDLINE database, Central Medical Library, and national peer-reviewed scientific journals in Bulgaria for the period from January 2008 to May 2020. 100 scientific publications have been found for a period of 12 years. Articles were selected according to PRISMA. Analyses include 17 articles that fully meet the preset criteria. Descriptive and variational analyses were carried out as basic statistical analyses. Mean values, standard deviation, minimum, maximum, and 95% confidence intervals have been determined. Results and discussion: Studies on this topic in EU Member States are obviously of interest, but publication activity is not high—only 17 scientific publications over a 12-year period. All 17 studies reflect cost savings after switching from a reference biological medicinal product to a biosimilar medicinal product, and the reduction in budgetary costs as a weighted average is about 30% of the total budgetary costs of biological therapies for the first 5 years. All 17 studies have reported that the use of biosimilar medicinal products is rather low. Although the quality, safety, and efficacy of biosimilar medicinal products have been unequivocally established, their introduction to the market is still insufficient.
{"title":"Evaluation of the drug utilization of biosimilar medicinal products containing monoclonal antibodies: A systematic review","authors":"E. Yordanov, I. Parvova, E. Hristov, V. Petkova","doi":"10.1177/17411343221076371","DOIUrl":"https://doi.org/10.1177/17411343221076371","url":null,"abstract":"Aim: The objective is to study the availability and affordability of biosimilar medicinal products containing monoclonal antibodies, measure their drug utilization, and evaluate the rational drug use globally through analysis and systematic review of scientific articles published in the scientific literature. Materials and methods: The documentary analysis of scientific publications was carried out by specific keywords in MEDLINE database, Central Medical Library, and national peer-reviewed scientific journals in Bulgaria for the period from January 2008 to May 2020. 100 scientific publications have been found for a period of 12 years. Articles were selected according to PRISMA. Analyses include 17 articles that fully meet the preset criteria. Descriptive and variational analyses were carried out as basic statistical analyses. Mean values, standard deviation, minimum, maximum, and 95% confidence intervals have been determined. Results and discussion: Studies on this topic in EU Member States are obviously of interest, but publication activity is not high—only 17 scientific publications over a 12-year period. All 17 studies reflect cost savings after switching from a reference biological medicinal product to a biosimilar medicinal product, and the reduction in budgetary costs as a weighted average is about 30% of the total budgetary costs of biological therapies for the first 5 years. All 17 studies have reported that the use of biosimilar medicinal products is rather low. Although the quality, safety, and efficacy of biosimilar medicinal products have been unequivocally established, their introduction to the market is still insufficient.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"39 1","pages":"145 - 153"},"PeriodicalIF":0.0,"publicationDate":"2022-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73224268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-17DOI: 10.1177/17411343221076960
Danielle C. Pfifferling
Compiled and written by Greenblum & Bernstein PLC A US intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: Inter partes Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing This section is intended to be a synopsis of recent developments and is not intended to be exhaustive. If any issue referred to in this section is to be relied upon, specific advice should be sought. Please contact: Paul A. Braier, PhD, Esq. Greenblum & Bernstein PLC 1950 Roland Clarke Place Reston, VA20191 USA Tel: +1 703 716 1191 Fax: +1 703 716 1180 Email: pbraier@gbpatent.com Web: www.gbpatent.com
Greenblum & Bernstein PLC是一家美国知识产权律师事务所，为包括生物技术和制药行业在内的所有行业提供与知识产权相关的全方位服务，包括:专利和商标诉讼专利起草和审查专利侵权和有效性意见专利复审程序和干扰新药战略市场进入战略合资企业战略许可本节旨在概述最近的发展，但并非详尽。如果要依赖本节中提到的任何问题，应寻求具体的建议。请联系:Paul A. Braier, PhD, Esq。Greenblum & Bernstein PLC 1950 Roland Clarke Place Reston, VA20191 USA Tel: +1 703 716 1191 Fax: +1 703 716 1180 Email: pbraier@gbpatent.com Web: www.gbpatent.com
{"title":"What’s the skinny on “Skinny” labels?","authors":"Danielle C. Pfifferling","doi":"10.1177/17411343221076960","DOIUrl":"https://doi.org/10.1177/17411343221076960","url":null,"abstract":"Compiled and written by Greenblum & Bernstein PLC A US intellectual property law firm which provides a full range of services in IP-related matters across all industries, including the biotech and pharmaceutical industries, including: Inter partes Review (IPR) and Post Grant Review (PGR) Abbreviated new drug applications (ANDAs) and Notice Letters Patent and trademark litigation Patent drafting and prosecution Patent infringement and validity opinions Patent reexamination proceedings and interferences New drug strategies Market entry strategies Joint venture strategies Licensing This section is intended to be a synopsis of recent developments and is not intended to be exhaustive. If any issue referred to in this section is to be relied upon, specific advice should be sought. Please contact: Paul A. Braier, PhD, Esq. Greenblum & Bernstein PLC 1950 Roland Clarke Place Reston, VA20191 USA Tel: +1 703 716 1191 Fax: +1 703 716 1180 Email: pbraier@gbpatent.com Web: www.gbpatent.com","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"1 1","pages":"51 - 55"},"PeriodicalIF":0.0,"publicationDate":"2022-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85856992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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