Pub Date : 2021-08-11DOI: 10.1177/17411343211065583
Abdul Fasi Mohammed
Patents are often seen as legal monopolies that impose exorbitant pricing, particularly for innovations in the pharmaceutical and medical device sectors where the inventions are usually protected through the patents. Many have argued that patent protection should not be extended to sectors where the public interest in obtaining those products or services is important, such as health-related products, which also includes the medications. This paper provides an overview of different policy choices that national governments might employ to both promote innovation in health-related goods and ensure low consumer prices for the basic medicines. Special consideration is given to the current COVID-19 health emergency and highlights the solutions through the published reviews to make the basic medications freely accessible to all countries.
{"title":"An overview on the various pricing policies of health-related products and incentivizing the innovation during the health emergency situations","authors":"Abdul Fasi Mohammed","doi":"10.1177/17411343211065583","DOIUrl":"https://doi.org/10.1177/17411343211065583","url":null,"abstract":"Patents are often seen as legal monopolies that impose exorbitant pricing, particularly for innovations in the pharmaceutical and medical device sectors where the inventions are usually protected through the patents. Many have argued that patent protection should not be extended to sectors where the public interest in obtaining those products or services is important, such as health-related products, which also includes the medications. This paper provides an overview of different policy choices that national governments might employ to both promote innovation in health-related goods and ensure low consumer prices for the basic medicines. Special consideration is given to the current COVID-19 health emergency and highlights the solutions through the published reviews to make the basic medications freely accessible to all countries.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"27 1","pages":"136 - 144"},"PeriodicalIF":0.0,"publicationDate":"2021-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77081083","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 : 2021-08-03DOI: 10.1177/17411343211030672
Samuel Nkansah, F. C. Bearden, Faustina Frempong-Ainguah, F. Nkansah
Escalating pharmaceutical expenditure is a global phenomenon, and Ghana has not been spared. To attend to the increasing cost of healthcare resulting from the high cost of drugs, the government of Ghana took a strategic decision to reduce its expenditure on healthcare without compromising the quality of care. The government directed that all medicines be prescribed by their generic names only at all health facilities. The purpose of this study is to assess the extent to which physicians adhere to the policy by assessing physicians' generic medicine prescribing patterns across the healthcare system in selected facilities in the Greater Accra Region. Questionnaires were administered to 87 physicians in 13 selected health facilities in Ghana. The results were analyzed using SPSS. The study's findings revealed that 74.7% of physicians adhere to the policy, and there is a likely relationship between knowledge of the policy and its implementation. Also, there is no significant relationship between health facility, physician's experience, disease diagnosis stage, and the prescribing of generic medicines. There is a need for regular review of the policy with aggressive and wellstructured in-service training on the subject and the introduction of pharmacists' substitution rights.
{"title":"Adherence to a generic medicine policy: A developing country's experience","authors":"Samuel Nkansah, F. C. Bearden, Faustina Frempong-Ainguah, F. Nkansah","doi":"10.1177/17411343211030672","DOIUrl":"https://doi.org/10.1177/17411343211030672","url":null,"abstract":"Escalating pharmaceutical expenditure is a global phenomenon, and Ghana has not been spared. To attend to the increasing cost of healthcare resulting from the high cost of drugs, the government of Ghana took a strategic decision to reduce its expenditure on healthcare without compromising the quality of care. The government directed that all medicines be prescribed by their generic names only at all health facilities. The purpose of this study is to assess the extent to which physicians adhere to the policy by assessing physicians' generic medicine prescribing patterns across the healthcare system in selected facilities in the Greater Accra Region. Questionnaires were administered to 87 physicians in 13 selected health facilities in Ghana. The results were analyzed using SPSS. The study's findings revealed that 74.7% of physicians adhere to the policy, and there is a likely relationship between knowledge of the policy and its implementation. Also, there is no significant relationship between health facility, physician's experience, disease diagnosis stage, and the prescribing of generic medicines. There is a need for regular review of the policy with aggressive and wellstructured in-service training on the subject and the introduction of pharmacists' substitution rights.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"8 1","pages":"99 - 109"},"PeriodicalIF":0.0,"publicationDate":"2021-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90211912","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 : 2021-07-26DOI: 10.1177/17411343211035168
P. Grootendorst
Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.
{"title":"Brand drug companies impeding generic drug company access to product samples: Estimated prevalence and impact on drug costs","authors":"P. Grootendorst","doi":"10.1177/17411343211035168","DOIUrl":"https://doi.org/10.1177/17411343211035168","url":null,"abstract":"Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"20 1","pages":"10 - 20"},"PeriodicalIF":0.0,"publicationDate":"2021-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87425141","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 : 2021-07-22DOI: 10.1177/17411343211033887
Ashish Miglani, Chandan Saini, P. Musyuni, G. Aggarwal
The pharmaceutical industry's primary concern is to provide high-quality drug products to the general public, so drug recalls play an important role in maintaining the quality system by removing defective products from the market. Pharmaceutical product recalls are increasing at an alarming rate as a result of increased inspection rates and the introduction of modernization and the digital world into the industry, raising concerns for regulatory agencies and public health to focus on more stringent regulations to control future recalls of defective drug products. This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.
{"title":"A review and analysis of product recall for pharmaceutical drug product","authors":"Ashish Miglani, Chandan Saini, P. Musyuni, G. Aggarwal","doi":"10.1177/17411343211033887","DOIUrl":"https://doi.org/10.1177/17411343211033887","url":null,"abstract":"The pharmaceutical industry's primary concern is to provide high-quality drug products to the general public, so drug recalls play an important role in maintaining the quality system by removing defective products from the market. Pharmaceutical product recalls are increasing at an alarming rate as a result of increased inspection rates and the introduction of modernization and the digital world into the industry, raising concerns for regulatory agencies and public health to focus on more stringent regulations to control future recalls of defective drug products. This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"26 1","pages":"72 - 81"},"PeriodicalIF":0.0,"publicationDate":"2021-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73521964","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 : 2021-07-04DOI: 10.1177/17411343211029995
N. Charyulu, Anoop Narayanan, A. Shetty
Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.
{"title":"Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council","authors":"N. Charyulu, Anoop Narayanan, A. Shetty","doi":"10.1177/17411343211029995","DOIUrl":"https://doi.org/10.1177/17411343211029995","url":null,"abstract":"Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"77 1","pages":"82 - 87"},"PeriodicalIF":0.0,"publicationDate":"2021-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79053279","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 : 2021-06-23DOI: 10.1177/17411343211008589
Z. Boru
The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics). Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.
{"title":"The anatomy of CUSMA’s patent: Does it still reflect an equipoise?","authors":"Z. Boru","doi":"10.1177/17411343211008589","DOIUrl":"https://doi.org/10.1177/17411343211008589","url":null,"abstract":"The Protocol of Amendment to the Agreement between the United States of America, Canada and the United Mexican States erased many of the TRIPS-plus provisions inserted earlier into the Canada- United States of America-Mexico Agreement (hereafter, CUSMA) signed on 30 November 2018. While the erasure of the provisions shows the contributions made to promote access to medicines, the Agreement still retains TRIPS-plus provisions, including the provisions on patent term extensions. Thus seen, irrespective of the changes introduced by the Protocol of Amendment, patent term extensions may have a negative implication on access to cost-cutting medicines (biosimilars and generics). Against this backdrop, this paper focuses on patent term extensions, as contained in the CUSMA’s Intellectual Property Rights (IPRs) chapter. The paper investigates if & how the patent term extension has the potential to impede access to affordable medicines (biologics and chemically synthesized medicines). In so doing, the paper provides possible responses to the question, do the provisions on patent term extensions hinder the timely access to affordable medicines? As such, the first part of the paper succinctly looks at CUSMA. Section “Patent protection under the TRIPS agreement” examines the TRIPS patent regime. While “The CUSMA’s rules on patent term extension” section discusses the nature of obligations included in the CUSMA’s IPRs chapter, the Section “The CUSMA’s rules on patent term extension vis-à-vis access to medicines” analyzes the potential implications of patent term extensions on access to affordable medicines. The final section concludes the paper.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"16 1","pages":"21 - 31"},"PeriodicalIF":0.0,"publicationDate":"2021-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89885770","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 : 2021-06-12DOI: 10.1177/17411343211023539
Chandan Saini, Ashish Miglani, P. Musyuni, G. Aggarwal
Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.
{"title":"Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA","authors":"Chandan Saini, Ashish Miglani, P. Musyuni, G. Aggarwal","doi":"10.1177/17411343211023539","DOIUrl":"https://doi.org/10.1177/17411343211023539","url":null,"abstract":"Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"2012 1","pages":"32 - 41"},"PeriodicalIF":0.0,"publicationDate":"2021-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72747760","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 : 2021-06-01DOI: 10.1177/1741134321999698
Paul A. Braier
{"title":"GlaxoSmithKline v. Teva: Federal circuit broadens induced infringement to preclude marketing generics for off-patent indications","authors":"Paul A. Braier","doi":"10.1177/1741134321999698","DOIUrl":"https://doi.org/10.1177/1741134321999698","url":null,"abstract":"","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"20 1","pages":"97 - 101"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72555037","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 : 2021-06-01DOI: 10.1177/17411343211013572
Keith A Zullow, Ci-Wen Chang, S. Anderson
In Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019), the Federal Circuit affirmed a judgment of invalidity of a patent claiming methods for treating Hepatitis C virus for, inter alia, lack of enablement. The Supreme Court denied Idenix’s petition for a writ of certiorari, meaning that the Federal Circuit decision stands, and genus claims covering thousands of compounds that were supported by an insufficient number of examples have failed the enablement test not once, but twice. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013). This case report presents the context surrounding the Federal Circuit’s Idenix decision and the Supreme Court’s decision not to hear the case.
{"title":"Idenix v. Gilead: The enablement and written description limits of a genus claim","authors":"Keith A Zullow, Ci-Wen Chang, S. Anderson","doi":"10.1177/17411343211013572","DOIUrl":"https://doi.org/10.1177/17411343211013572","url":null,"abstract":"In Idenix Pharms. LLC v. Gilead Sci. Inc., 941 F.3d 1149 (Fed. Cir. 2019), the Federal Circuit affirmed a judgment of invalidity of a patent claiming methods for treating Hepatitis C virus for, inter alia, lack of enablement. The Supreme Court denied Idenix’s petition for a writ of certiorari, meaning that the Federal Circuit decision stands, and genus claims covering thousands of compounds that were supported by an insufficient number of examples have failed the enablement test not once, but twice. See Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380 (Fed. Cir. 2013). This case report presents the context surrounding the Federal Circuit’s Idenix decision and the Supreme Court’s decision not to hear the case.","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"71 1","pages":"77 - 83"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73605549","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 : 2021-06-01DOI: 10.1177/17411343211020525
B. Tempest
A USA watchdog agency recently warned that the backlog of FDA inspection could take years to complete. By comparison, some discovery pharmaceutical companies and some OTC companies along with one middle eastern generic pharmaceutical company have a debt ratio of around x1.5 gross debt/EBITDA. The largest generic pharmaceutical company Viatris (Pfizer-Upjohn-Mylan) expects 2021 sales to be dominated by Europe, with a 33% share of total sales (growing at +4% over the last year) compared to North America holding a smaller 27% share of total sales (which is declining at -1%). [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 abstract 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 abstract. (Copyright applies to all Abstracts.)
一家美国监管机构最近警告说，积压的FDA检查可能需要数年时间才能完成。相比之下，一些发现制药公司和一些OTC公司以及一家中东仿制药公司的负债率约为总债务/EBITDA的x1.5。最大的仿制药公司Viatris (pfizer - upjohnmylan)预计，2021年销售额将由欧洲主导，占总销售额的33%(去年增长+4%)，而北美占总销售额的27%(下降-1%)。[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。这篇摘要可以删节。对副本的准确性不作任何保证。用户应参考资料的原始出版版本以获取完整摘要。(版权适用于所有摘要。)
{"title":"Journal of Generic Medicine – Editorial June 2021","authors":"B. Tempest","doi":"10.1177/17411343211020525","DOIUrl":"https://doi.org/10.1177/17411343211020525","url":null,"abstract":"A USA watchdog agency recently warned that the backlog of FDA inspection could take years to complete. By comparison, some discovery pharmaceutical companies and some OTC companies along with one middle eastern generic pharmaceutical company have a debt ratio of around x1.5 gross debt/EBITDA. The largest generic pharmaceutical company Viatris (Pfizer-Upjohn-Mylan) expects 2021 sales to be dominated by Europe, with a 33% share of total sales (growing at +4% over the last year) compared to North America holding a smaller 27% share of total sales (which is declining at -1%). [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 abstract 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 abstract. (Copyright applies to all Abstracts.)","PeriodicalId":15914,"journal":{"name":"Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector","volume":"28 1","pages":"47 - 48"},"PeriodicalIF":0.0,"publicationDate":"2021-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87773375","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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