GaBI Journal-Generics and Biosimilars Initiative Journal最新文献

{"title":"A critical review of substitution policy for biosimilars in Canada","authors":"Philip Schneider, M. Reilly","doi":"10.5639/gabij.2021.1003.016","DOIUrl":"https://doi.org/10.5639/gabij.2021.1003.016","url":null,"abstract":"Abstract: Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the population in Canada, have now implemented policies requiring non-medical switching of biosimilars – switching from a patient from an originator biological to a biosimilar primarily for economic reasons. In this article, we compare biosimilar substitution policies in Canada to policies in Europe and the US, finding an enhanced focus on clinical and marketplace factors in these regions. We also find evidence that in some cases non-medical switching may pose a risk to patients and suggest that Canada could learn from more mature markets, such as those in Europe, where switching policies better consider patient needs, preserve physician choice and promote market competition.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88505433","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":"Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US","authors":"Charles L. Bennett","doi":"10.5639/gabij.2021.1003.015","DOIUrl":"https://doi.org/10.5639/gabij.2021.1003.015","url":null,"abstract":"Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"73 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77011915","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":"Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching","authors":"Mansour Somaily, Hana S Alahmari, W. Abbag, Shahenda Yousif, Nawar Tayfour, N. Almushayt, Saleh Alhusayni, Saeed Almajadiah","doi":"10.5639/gabij.2021.1002.007","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.007","url":null,"abstract":"Background: A biosimilar version of infliximab ( CT-P13) was recently approved for use in Saudi Arabia. Clinical data support its use in the treatment of rheumatic disease, however, there is a lack of local data regarding the efficacy and tolerability of CT-P13 among patients with rheumatological disorders in Saudi Arabia. Objectives: To investigate the feasibility, tolerability and immunogenicity of switching from originator infliximab to biosimilar infliximab, CT-P13, in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and Behçet’s disease (BD). Methodology: The study included patients who were being treated with originator infliximab in the Department of Rheumatology in Khamis Mushayt General Hospital, Saudi Arabia, and were required to switch to biosimilar infliximab (CT-P13) between January 2018 and June 2019. Patient follow-up was carried out every three months for one year. The disease activity score 28 (DAS28) was used to assess RA severity. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was used to measure disease activity in patients with AS, while BD disease activity was based on clinical assessment. Results: In total, 13 patients (six with RA, five with AS and two with BD) were switched to biosimilar infliximab. The majority (n = 11/13) remained on biosimilar infliximab throughout the follow-up period with no reported major adverse events. Overall, there was a significant improvement in RA disease activity following biosimilar treatment, with the mean DAS28 decreasing from 3.61±1.24 before biosimilar therapy to 2.63±1.54 one year after switching. Conclusion: In patients with AS, BD, or RA who switched from originator infliximab to the biosimilar, CT-P13, we did not observe any significant differences in tolerability or efficacy between biosimilar and originator. Furthermore, disease activity significantly declined in RA patients following biosimilar treatment","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82764119","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":"An overview of the current status of follow-on biologicals in Iran","authors":"Farhang Rezaei, N. Anjidani","doi":"10.5639/gabij.2021.1002.010","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.010","url":null,"abstract":"Background The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe and chronic diseases. The goal of the present study was to provide an overview of their current status in Iran. Methods A comprehensive search of clinical trial registry sites and other databases that publish scholarly articles, such as PubMed and Google scholar, enabled the current follow-on biologicals landscape in Iran to be mapped. In addition, the annual national wholesale data of pharmaceutical products published by the Iranian pharmaceutical regulatory were analysed. The share of biotechnological therapeutics in terms of the whole medicines market, was evaluated, along with the share of follow-on biologicals and the potential and actualized cost-saving associated with using them. Data were collected and analysed over the 2013–2018 time period. Results At the time of writing, 21 follow-on biologicals were available in Iran and these are related to 17 different originator molecules. In 2018, approximately 13.5% of medicines spending in Iran was devoted to biotechnological therapeutics. Follow-on biologicals comprised approximately 47.2% of the biotechnological therapeutics’ total market value, up from 35.2% in 2013. The use of follow-on biologicals in Iran was associated with more than US$300 million cost-saving in 2018. A number of follow-on biological candidates, mostly monoclonal antibodies, are under development and will be subject to head-to-head clinical trials against originator products prior to regulatory approval and marketing. Conclusion Despite a significant rise in the use of follow-on biologicals in Iran, the proportional use of biotechnological therapeutics compared to the total medicines market has remained constant in recent years. Iranian healthcare authorities can improve patients’ access to life-saving biological medicines through promoting the use of follow-on biologicals instead of costly originators after making sure of the quality, efficacy and safety of the follow-on biologicals. The significant cost saving associated with using follow-on biologicals can also be utilized for other biotechnological medicines that are not currently in Iran’s drug list.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87967423","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":"The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes","authors":"Marta Zuccarelli, Benjamin Micallef, Mark Cilia, A. Serracino-Inglott, J. Borg","doi":"10.5639/gabij.2021.1002.009","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.009","url":null,"abstract":"Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims to describe the regulatory experience of approving biosimilars in the European Union (EU) within the EU framework, identify emerging trends in the EU regulatory pathway when approving biosimilars and discuss where the EU biosimilar framework is heading. Methods: Marketing authorisation applications (MAAs) submitted up to 2019 were retrieved from the public domain. The European public assessment report database was searched for approved biosimilars and clinical development programmes of biosimilars belonging to the same class were reviewed. In order to observe if biosimilars released onto the market increased safety concerns, we compared disproportionate adverse event reports pre- and post-licensure. Results: Up to December 2019, 90 MAAs were submitted and 53 biosimilars were approved for 14 different biologicals. Total number of clinical trials (both phase I and III) steadily goes up driven by an increase number of approvals in later years, while the average number of both phase I and III trials decreased over time with some with Pegfilgrastim biosimilars being approved without conducting any phase III clinical trials. No new safety concerns were identified from the analysis of disproportionate adverse event reports. Discussion: Clinical development programmes of biosimilars and the requirements set for biosimilars approval are changing over time. Biosimilars approved seem to be as well tolerated as the reference products when approved based on stringent regulatory requirements. Conclusion: Regulation of biosimilars is progressing as more knowledge is gained.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75832683","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":"Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation","authors":"K. Canham, C. Newcomb","doi":"10.5639/gabij.2021.1002.006","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.006","url":null,"abstract":"Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies have indicated patients prefer autoinjectors to other injection methods, however, patients must be able to demonstrate safe and effective use of an autoinjector for it to be a viable option. The YLB113 etanercept autoinjector may be a substitutable biosimilar to reference etanercept (Pfizer Manufacturing, Puurs, Belgium). This study sought to confirm intended users of the YLB113 etanercept autoinjector could demonstrate safe and effective use. Methods: The evaluation was performed among 79 participants representative of intended YLB113 etanercept autoinjector users; and included patients, caregivers and healthcare providers (HCPs). Results: All participants successfully delivered two simulated doses of etanercept into the foam pad using the autoinjector. Some participants experienced user errors, use difficulties, or close calls while simulating injection or answering knowledge questions. Discussion: In this usability evaluation, study patients, caregivers and HCPs demonstrated a high rate of injection success using the YLB113 etanercept autoinjector. Conclusions: The study results support demonstration of safe and effective use of the YLB113 etanercept autoinjector, a substitutable biosimilar to reference etanercept.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78157681","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":"Repurposing non-oncology drugs for cancer treatment","authors":"","doi":"10.5639/gabij.2021.1002.011","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.011","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89827669","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":"What to look forward to in GaBI Journal, 2021, Issue 2","authors":"P. Walson","doi":"10.5639/gabij.2021.1002.005","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.005","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"107 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79380106","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":"First 2021 GaBI Journal issue highlights","authors":"P. Walson","doi":"10.5639/GABIJ.2021.1001.001","DOIUrl":"https://doi.org/10.5639/GABIJ.2021.1001.001","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"21 1","pages":"3-3"},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81042330","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":"Biosimilars – status in July 2020 in 16 countries","authors":"Hye-Na Kang, R. Thorpe, I. Knezevic, Daehyun Baek, Parichard Chirachanakul, H. M. Chua, D. Dalili, F. Foo, K. Gao, Suna Habahbeh, Hugo Hamel, E. Nkansah, M. Savkina, O. Semeniuk, Shraddha Srivastava, João Tavares Neto, M. Wadhwa, Teruhide Yamaguchi","doi":"10.5639/gabij.2021.1001.002","DOIUrl":"https://doi.org/10.5639/gabij.2021.1001.002","url":null,"abstract":"The World Health Organization has provided specific guidance for biosimilar products to assist regulators, manufacturers and other professionals involved in the development and evaluation of these products. The development and approval of biosimilars are important for health care, as they allow the marketing of safe, efficacious and affordable biological products. Since the first biosimilars were approved in the EU in 2006, a series of biosimilars have been approved in many countries/geographical regions. This manuscript provides the figures on the status of approved biosimilars in 16 countries based on the information from regulatory experts and from publicly available data. It is clear that increasing numbers of biosimilars are now available in many countries and provide more options for treatments. It is expected that adoption of biosimilars will allow affordable health care and greater patient access to important medicinal products. It will also contribute to the overall WHO goal recognized by the World Health Assembly in 2014 by adopting a resolution on access to biotherapeutic products including biosimilars and on ensuring their quality, safety and efficacy.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":"33 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76946728","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}