Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector最新文献

{"title":"EU Legal and Regulatory Update","authors":"R. Milchior, S. Charbonnel","doi":"10.1177/17411343221081718","DOIUrl":"https://doi.org/10.1177/17411343221081718","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:","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"31 1","pages":"56 - 66"},"PeriodicalIF":0.0,"publicationDate":"2022-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73629513","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}

{"title":"Journal of Generic Medicine – Editorial March 2022","authors":"B. Tempest","doi":"10.1177/17411343221080636","DOIUrl":"https://doi.org/10.1177/17411343221080636","url":null,"abstract":"Predictions for 2022 continue. Many pharmaceutical companies have upgraded their earnings forecasts with bullish tentative expectations for 2022. Complex injectable manufacturers seem to do particularly well. UNICEF is projecting that the global production capacity of vaccines will expand to 40 billion doses in 2022 from 8 billion in 2021. Quite an increase. Capacities are rising in a range of countries including Senegal, Egypt, South Africa, Morocco and India. On the adverse side, shipping costs continue to increase alongside raw materials and APIs. In 2022, Perrigo has waved goodbye to its generic prescription business whilst J&J, Pfizer, GSK, Merck and Sanofi have all decided to spin off their consumer businesses. Vertical integration seems to be a major strategy at Amazon as seen in the recent purchase ofMGM studios to assist in the production of original Prime video. Some observers believe this approach may carry Amazon into the generic pharmaceutical industry in the future. In addition, Amazon already owns Pillpack which could evolve into a new distribution arm as well as synergising with a large generic pharmaceutical acquisition. Indeed, there are a couple of large Western generic companies having a challenging time at present which come to mind. In the USA, the FDA has now paused all domestic USA nonmission-critical inspections. This slowdown has been brought into force to ensure the safety of FDA employees and the companies it regulates in the light of the rise of omicron COVID-19 cases. This pause will increase the agency’s backlog of worldwide inspections. In spite of this news, some Indian facilities have still received warning letters in recent times following 2021 inspections. Interestingly, the FDA has advised API manufacturers to consider using alternative excipients such as sodium carbonate and ascorbic acid in order to inhibit the formation of nitrosamines which have caused so much trouble in the API industry in the last couple of years. In India, 55 manufacturers have benefitted from the new production-linked incentive (PLI) scheme introduced by the Indian Government. The PLI scheme offers financial incentives on sales increases over the next 6 years. The total cost of the scheme is quoted at over $1.5 billion. There were reported to be 278 applicants spread across three different categories which are defined by business sales and manufacturing focus. As Indian pharmaceutical companies expand into the Chinese marketplace, there are a growing number of alliances being established between Indian pharmaceutical companies and Chinese generic companies. In Europe, the European Commission seems more focussed on the generic industry these days compared to the past, and a recent report has identified that biosimilars saved European countries over $5 billion in 2021. Healthcare costs are rising, and the UK now spends 13% by value of its economic output on healthcare which makes it one of the highest in Europe. In this issue, we continu","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"35 1","pages":"3 - 3"},"PeriodicalIF":0.0,"publicationDate":"2022-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90852005","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}

{"title":"Retrospective analysis of drug utilization and rational drug use in treatment of essential arterial hypertension in Bulgaria: Generic perception","authors":"Nikolay Nachev, S. Stoyanova, A. Rangelov, E. Yordanov, Emil I Hristov, I. Parvova, V. Petkova","doi":"10.1177/17411343211055896","DOIUrl":"https://doi.org/10.1177/17411343211055896","url":null,"abstract":"Aim: To analyze drug utilization and rational drug use in treatment of essential arterial hypertension in Bulgaria by using quantitative and qualitative parameters at national level. To assess generic penetration as a part of rational drug use. Materials and methods: Design: retrospective study of publicly accessible data from registries of National health insurance fund for the period January–December 2017. The analyses are in accordance with ATC/DDD methodology of WHO. The data was processed via descriptive statistical methods. Results: The analyzed population includes 185 671 patients with essential arterial hypertension—13.33% of all hypertensive patients. The expenses for 2017 are 9 796 940.12 BGN (Bulgarian leva; 1 Euro=1.95,585 BGN). The expense per patient per year is 52.76 BGN, monthly expense is 4.40 BGN and daily expense is 0.14 BGN. The sum of 9 796 940.12 BGN is divided into two groups—expenses for monoproducts 65.88% and expenses for combined products 34.12%. Blockbusters are INNs lercanidipine and nebivolol. The total expenses for uncomplicated essential arterial hypertension are 1.22% of the total expenses. With this resource, 1.6 DDD/Patient/Day is provided. Discussion: In Bulgarian therapeutic practice, the most prescribed products are beta-blockers nebivolol and bisoprolol, calcium antagonist lercanidipine, and centrally acting antiadrenergic agents rilmenidine and moxonidine. Sartanes are represented mainly by valsartan. In all section analyses, the considerable use of lercanidipine is evident. Reference (original) medicinal products are mainly prescribed, while the market share of generic products, both in terms of costs and DDD, is significantly lower. Obtained results are inconsistent with European recommendation, while lack of national pharmacotherapeutic guideline poses a serious challenge.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"12 1","pages":"88 - 98"},"PeriodicalIF":0.0,"publicationDate":"2022-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87732650","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}

{"title":"Evaluation of the knowledge and perception of the Lebanese physicians toward generics and barriers to their prescription: A cross-sectional survey","authors":"Georges Hatem, Farah Mcheik, Mathijs Goossens, S. Awada","doi":"10.1177/17411343211056249","DOIUrl":"https://doi.org/10.1177/17411343211056249","url":null,"abstract":"Generic substitutions practice is increasingly encouraged by health authorities. The use of cheaper generic drugs is often promoted as a measure to reduce the health care expenditure on pharmaceutical products, and save money to patients as well as governments. The current study aimed to explore the knowledge, perception, and attitude of physicians toward generic medicines in Lebanon and potential barriers to generic use and finally their confidence in the Lebanese pharmacist in the whole healthcare sector. A random sample of 385 physicians was recruited from different regions across Lebanon either by visiting their private clinics or in different hospitals. Among the respondents, 115 (29.9%) reported that they prefer to prescribe generic medicines over the innovator product and 258 (68.3%) reported that a generic medicine has the same therapeutic effect as the brand medicine. However, 181 (47.9%) respondents reported that a generic medicine should have the same active ingredient as the branded medicine and 357 (94.4%) reported that they do not have same excipients. When asked about their trust in the pharmacist in the health care system, almost 229 (59.5%) of respondents reported distrust. The majority of the physicians who participated in this survey indicated a low generic medicine prescription rate. They preferred to use and prescribe brand medicines. This phenomenon was observed in all of the age groups and was independent of their year, their place of graduation and experience but directly depends on the type of certificate.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"38 1","pages":"168 - 175"},"PeriodicalIF":0.0,"publicationDate":"2022-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73428968","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}

{"title":"Journal of Generic Medicine – Editorial December 2021","authors":"B. Tempest","doi":"10.1177/17411343211058793","DOIUrl":"https://doi.org/10.1177/17411343211058793","url":null,"abstract":"Inspections by the FDA of Indian plants restarted around September 2021 after the pandemic shutdown with representatives from both the Indian and USA FDA offices in attendance. For generic drug facilities registered with the USA FDA at the end of 2021, India continues to have the largest number of Active Pharmaceutical Ingredient (API) manufacturing facilities (183). After the lowering of generic medicine prices in the first half of 2021, USA medicines prices seem to have stabilised in the last quarter. [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":"1 1","pages":"173 - 173"},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89633751","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}

{"title":"A recent history of pharma and biotech patent appeals to the U.S. court of appeals for the federal circuit","authors":"Paul A. Braier","doi":"10.1177/17411343211056254","DOIUrl":"https://doi.org/10.1177/17411343211056254","url":null,"abstract":"Compiled and written by Greenblum & Bernstein PLC AUS 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, VA 20191 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":"87 1","pages":"220 - 224"},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81190669","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}

{"title":"Journal of Generic Medicines – Editorial September 2021","authors":"Dr Brian W. Tempest","doi":"10.1177/17411343211039927","DOIUrl":"https://doi.org/10.1177/17411343211039927","url":null,"abstract":"Many industry observers are now taking this opportunity to communicate their view of the future. IQVIA anticipates the spending on all medicines will grow at 3–6% through to 2025 reaching a total global market of $1600 billion. This includes Covid vaccine sales of $157 billion. Developing countries will grow in double-digits led by Russia, Pakistan, Vietnam, India, Brazil, China and faster than most developed countries. Oncology and immunology medicines are also expected to grow in double digits as a result of better access and new treatments. Indeed, the number of New Active Substances (NAS) introductions is expected to be above normal at around 60 per year. The International Generic and Biosimilar Medicines Association have published their vision of the future and assessed today’s value of the global generic Industry at $390 billion. Generic medicines represent a 60–80% share of all the medicines consumed in many key countries with an even higher share of 90% in the USA and India. More importantly, the disease burden on patients in India and Africa has now dropped by more than 35% over the last 25 years though access to generic medicines. Another research company has projected that the global generic industry will reach $508 billion by 2026. The small molecule segment will reach $325 billion alongside the biosimilar segment at $183 billion. The two largest generic markets are expected to be the USA at $116 billion and China at $91billion. Astonishingly, the UK government has ignored the generic medicines industry in its new 10-year strategy for the life sciences sector whilst every day it depends on the industry for its daily supply of medicines to pharmacies, hospitals and doctor surgeries in the UK. In the last quarter, some Asian generic companies showed encouraging prescription trends. The generic prescriptions in the USA market filled by the Indian Pharmaceutical companies showed a 6% year on year growth (excluding vaccines). Meanwhile several western generic companies fell short of their historical 2020 results and seem to be facing competitive challenges with the USA pricing erosion remaining high in the mid-single digits. On Covid, one of the vaccine challenges has been to determine if the third booster vaccination will be needed just once or every year. Many generic companies have been in-licensing Covid vaccines and treatments from around the world. One generic company has even negotiated five separate licences for covid treatments including the mabs, the nibs and the virs. The Active Pharmaceutical Ingredients market is expected to be driven by high potency molecules in the future, but is currently facing a significant rise in raw material costs. In addition, packaging costs have doubled and the freight costs from China have tripled. As a consequence, the number of Active Pharmaceutical Ingredients imported into India from China are reducing. Furthermore, product discontinuations resulting from trace nitrosamines have continued in So","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"1 1","pages":"105 - 105"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82697996","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}

{"title":"U.S. v. Arthrex: Supreme Court to provide long awaited resolution","authors":"Enoch E. Peavey","doi":"10.1177/17411343211017266","DOIUrl":"https://doi.org/10.1177/17411343211017266","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"65 4","pages":"154 - 156"},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72588428","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}

{"title":"Patients’ beliefs toward generic medication in Yemen","authors":"A. Jaber, Y. Al-Worafi, A. Dhabali","doi":"10.1177/17411343211039267","DOIUrl":"https://doi.org/10.1177/17411343211039267","url":null,"abstract":"Purpose This study aims to explore patients’ knowledge and beliefs toward generic medicines and identify the factors affecting their beliefs toward them in Yemen. Patients and methods A cross-sectional study was conducted from April 1 to July 1, 2016. A self-administered questionnaire was distributed to 590 adult patients in Sana’a. The data were analyzed using Statistical Package for the Social Sciences® (IBM SPSS) version 26 for Windows. Results Overall, 370 patients participated in this study. The study identified that a majority of the respondents did not know the similarities and differences between generic and branded medication and had negative beliefs toward generic medication. The study identified the factors contributing to the patients’ beliefs toward generic medication. Conclusion Yemeni patients had poor knowledge and negative beliefs toward generic medication. Educational programs provided to patients and healthcare professionals regarding generic medication can improve patients’ knowledge and correct their beliefs in this regard.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"41 1","pages":"110 - 115"},"PeriodicalIF":0.0,"publicationDate":"2021-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77644964","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}

{"title":"Recent court orders in patent suits on limits of Bolar exemption: Shrinking space for pharmaceutical generic companies in India?","authors":"Sandeep K Rathod, Priyam Lizmary Cherian, Ketki P Jha","doi":"10.1177/17411343211038999","DOIUrl":"https://doi.org/10.1177/17411343211038999","url":null,"abstract":"The generic pharmaceutical sector in India transformed over the last few decades. However, certain recent judicial developments may impact the flexibility that generic companies have for development of future generics. This article looks at some of these developments. The developments covered are: a) interpretation and application of the Bolar flexibilities and b) hurdles in claiming use under S.107 A.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"89 1","pages":"154 - 167"},"PeriodicalIF":0.0,"publicationDate":"2021-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77205112","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}