Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector最新文献_第6页

Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria 保加利亚含有单克隆抗体的生物类似药的可得性、可负担性和药物利用情况

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-05-20 DOI: 10.1177/17411343211017627

S. Stoyanova, E. Yordanov, E. Hristov, I. Parvova, Hristo Tzachev, V. Petkova

{"title":"Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria","authors":"S. Stoyanova, E. Yordanov, E. Hristov, I. Parvova, Hristo Tzachev, V. Petkova","doi":"10.1177/17411343211017627","DOIUrl":"https://doi.org/10.1177/17411343211017627","url":null,"abstract":"The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"21 1","pages":"42 - 50"},"PeriodicalIF":0.0,"publicationDate":"2021-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87225857","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}

引用次数: 3

US trade policy is putting at risk the sustainability of the generic/biosimilar industry and the drug supply chain 美国的贸易政策正使仿制药/生物仿制药行业和药品供应链的可持续性面临风险

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-05-04 DOI: 10.1177/1741134321994316

M. F. Jorge

引用次数: 0

Does regulatory chill still concern states? 监管寒意还会影响各州吗?

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-04-22 DOI: 10.1177/17411343211001424

Z. Boru

{"title":"Does regulatory chill still concern states?","authors":"Z. Boru","doi":"10.1177/17411343211001424","DOIUrl":"https://doi.org/10.1177/17411343211001424","url":null,"abstract":"Public health measures taken by States have been subject to mounting arbitration legal challenges. These challenges resulted in an argument that investment agreements in general and the prevalence of the Investor-State Dispute Settlement (ISDS) mechanism, in particular, may force governments to refrain from introducing new legislative or policy measures due to a fear that the measures could be contested by investors. This situation, a fear to adopt legislative and similar other measures, is often referred to as “regulatory chill.” Recent arbitration cases show, however, that some of the cases involving pharmaceutical and similar other companies have been decided in favor of State Parties to the ISDS. In this regard, the legal claims initiated by Eli Lilly against the Government of Canada or the arbitration claims brought by Philip Morris against the Government of Australia and Uruguay can be cases in point. Due to these recent cases, some scholars have argued that the ISDS decisions (such as Eli Lilly and Government of Canada) demonstrate that regulatory chill may not be States’ concern anymore. This paper examines the obligations of State Parties to the International Covenant on Economic, Social and Cultural Rights (ICESCR or Covenant) to ensure access to affordable health technologies (medicines, vaccines, etc.) and the likelihood of investment agreements to result in a “regulatory chill” that hinders the realization of the obligations. In order to do so, the paper takes the TPP’s (now CPTPP) investment chapter as a case in point.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"3 1","pages":"195 - 205"},"PeriodicalIF":0.0,"publicationDate":"2021-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72946390","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}

引用次数: 0

World trade organization’s export-oriented compulsory licensing mechanism: Foreseen policy concern for Africa to mitigate the COVID-19 pandemic 世界贸易组织以出口为导向的强制许可机制:可预见的非洲缓解COVID-19大流行的政策关切

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-04-22 DOI: 10.1177/17411343211010205

M. Z. Abbas

引用次数: 0

Use of generic medicines in the Middle East: Knowledge, perceptions and experiences of the Sulaimani population, KRI, Iraq 中东仿制药的使用:苏莱曼尼人口的知识、观念和经验，伊拉克KRI

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-04-14 DOI: 10.1177/17411343211008948

Ramazan Uctu

{"title":"Use of generic medicines in the Middle East: Knowledge, perceptions and experiences of the Sulaimani population, KRI, Iraq","authors":"Ramazan Uctu","doi":"10.1177/17411343211008948","DOIUrl":"https://doi.org/10.1177/17411343211008948","url":null,"abstract":"The aim of this study is to assess the level of knowledge, perception, and experiences of the Sulaimani population in KRI, Iraq. A descriptive and cross-sectional survey was performed with 389 participants (283 male, 106 female) in the city of Sulaimani. The main method of collecting data was done through a questionnaire which was made up of two sections; firstly assessing the demographic characteristics of the sample population, and secondly assessing their knowledge towards generic medicines and their perceptions of generic medicine usage and purchasing intention. The Cronbach’s alpha coefficient was 0.726 which is considered as an acceptable value to measure internal consistency of the sampled population. As a result, this study showed that the sampled population did not have sufficient knowledge about generic medicines and would therefore also not be considering replacing branded medicines with the generics. This is mostly related to poor awareness of generic medicines and lack of publicity or awareness campaigns surrounding generic medicines. This study recommends that authorities invest in publicizing the use of generics and implement public awareness campaigns.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"10 1","pages":"206 - 213"},"PeriodicalIF":0.0,"publicationDate":"2021-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78920725","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}

引用次数: 4

Regulatory approaches: Global medical device tracking advancement in USA, EU and India 监管方法:美国、欧盟和印度的全球医疗器械跟踪进展

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-04-07 DOI: 10.1177/17411343211005070

G. Saini, M. Choudhary, V. Budhwar, Tarif Hussain

引用次数: 0

Regulatory scenario of pharmaceutical advertisement in India, USA and Australia: A comparative study 印度、美国和澳大利亚药品广告监管情景的比较研究

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-03-27 DOI: 10.1177/17411343211005093

V. Budhwar, Tarif Hussian, M. Choudhary, G. Saini

引用次数: 0

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review 美国和欧洲非专利固体剂型上市许可的监管档案要求的比较:综述

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-03-12 DOI: 10.1177/17411343211000788

Lovely Joylein, Bishop Adhikari, Megha Chellath Kottayi, G. Ravi, A. Dubey

{"title":"Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review","authors":"Lovely Joylein, Bishop Adhikari, Megha Chellath Kottayi, G. Ravi, A. Dubey","doi":"10.1177/17411343211000788","DOIUrl":"https://doi.org/10.1177/17411343211000788","url":null,"abstract":"Pharmaceutical solid dosage forms are categorized into several types based on the purpose, usage, and route of administration. Some examples of frequently available solid dosage forms include tablets, capsules, lozenges, powders, and granules. A generic drug is one of usually intending to be interchangeable with the innovator product, thereby making it essential for them to mimic the innovator drug concerning their safety and efficacy profiles. The essential concept of making a generic drug available hinges on its economic benefits towards the patient population as well as its feasibility in the development of benefits the pharmaceutical companies. Additionally, generic drugs expand the market of a particular API, thereby ensuring that an adequate number of medications are made available to cater to the needs of every patient and further preventing any issues arising out of drug shortages. The USFDA and the EMA, being two of the leading regulatory agencies across the globe, have long been associated with the development and drafting of regulations about the approval of generic drug products. A firm understanding of the regulatory requirements associated with the preparation of a generic drug dossier will aid pharmaceutical manufacturers in attaining favourable outcomes when desiring multicounty submissions, thereby ensuring a smooth review process without any substantial delays.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"14 1","pages":"174 - 182"},"PeriodicalIF":0.0,"publicationDate":"2021-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87629743","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}

引用次数: 0

Parallel importation as a policy option to reduce price of patented health technologies 平行进口作为降低专利卫生技术价格的政策选择

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-02-25 DOI: 10.1177/1741134321999418

M. Z. Abbas

引用次数: 1

Courts address venue for cases brought under the Hatch-Waxman Act 法院处理根据哈奇-韦克斯曼法案提起的案件的地点

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector Pub Date : 2021-02-20 DOI: 10.1177/1741134321992396

S. Hamidinia, Paul A. Braier

引用次数: 0