Pub Date : 2020-06-15DOI: 10.5639/gabij.2020.0902.015
Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes. This paper provides some insights on these aspects.
{"title":"Biosimilars markets: US and EU compared","authors":"","doi":"10.5639/gabij.2020.0902.015","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.015","url":null,"abstract":"Differences between the US and European regulatory processes can lead to differences in the time taken for biosimilar approval. The European Medicines Agency is in some cases quicker to approve biosimilar drugs and Europe has overall more approved biosimilars, whilst the US approved the first biosimilar in 2015. Whatever the market, there are a number of strategies that can be employed to help address patient and healthcare provider concerns, such as educational programmes. This paper provides some insights on these aspects.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82935952","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 : 2020-06-15DOI: 10.5639/gabij.2020.0902.009
A. Astier
Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used.
{"title":"Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals","authors":"A. Astier","doi":"10.5639/gabij.2020.0902.009","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.009","url":null,"abstract":"Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher order structures. It finds that, although other methods exist, spectroscopic methods remain most commonly used.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80756694","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 : 2020-06-15DOI: 10.5639/gabij.2020.0902.014
Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried out for trastuzumab biosimilars.
{"title":"Clinical trials for trastuzumab biosimilars","authors":"","doi":"10.5639/gabij.2020.0902.014","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.014","url":null,"abstract":"Clinical trials must demonstrate biosimilarity for regulatory marketing approval to be granted. The GaBI Journal has conducted a search for clinical trials that have been, or are being, carried out for trastuzumab biosimilars.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82885747","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 : 2020-06-15DOI: 10.5639/gabij.2020.0902.013
P. Schneider, M. Reilly
Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs of an ageing population, mean the cost of these medicines and the burden on governments and insurance companies is growing. However, the introduction of biosimilars has broadened treatment choices for physicians and their patients and, by increasing competition, reduced healthcare expenditures. The biosimilar market in Europe is the largest in the world, representing approximately 60% of the global biosimilar market and growing consistently year on year. As of October 2019, 54 biosimilars of 15 originator biological medicines have marketing authorization in Europe. European countries, with their large biosimilar markets and diverse healthcare systems, serve as valuable examples of different approaches to biosimilar policy. Several studies, research papers and position statements have been published on such policies. These findings, along with real-world policy and procurement examples from European countries, provide an opportunity for other countries to learn from. This paper will review the different approaches to biosimilar policy across the European continent, highlighting principles which can be applied to develop an efficient and sustainable biosimilar market.
{"title":"Policy recommendations for a sustainable biosimilars market: lessons from Europe","authors":"P. Schneider, M. Reilly","doi":"10.5639/gabij.2020.0902.013","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.013","url":null,"abstract":"Approximately 25% of all new medicines approved in recent years and in development today are biologicals. The complexity of biologicals, the investment needed to meet ever more stringent regulatory and payer requirements, combined with the needs of an ageing population, mean the cost of these medicines and the burden on governments and insurance companies is growing. However, the introduction of biosimilars has broadened treatment choices for physicians and their patients and, by increasing competition, reduced healthcare expenditures. The biosimilar market in Europe is the largest in the world, representing approximately 60% of the global biosimilar market and growing consistently year on year. As of October 2019, 54 biosimilars of 15 originator biological medicines have marketing authorization in Europe. European countries, with their large biosimilar markets and diverse healthcare systems, serve as valuable examples of different approaches to biosimilar policy. Several studies, research papers and position statements have been published on such policies. These findings, along with real-world policy and procurement examples from European countries, provide an opportunity for other countries to learn from. This paper will review the different approaches to biosimilar policy across the European continent, highlighting principles which can be applied to develop an efficient and sustainable biosimilar market.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79563617","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 : 2020-06-15DOI: 10.5639/gabij.2020.0902.012
Kevin Klein
{"title":"Poor traceability of biologicals in UK ADR reporting indicates the need for improvements to ensure patient safety","authors":"Kevin Klein","doi":"10.5639/gabij.2020.0902.012","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.012","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82582579","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 : 2020-03-15DOI: 10.5639/gabij.2020.0901.006
G. R. Soni
As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to its classification as a ‘non-innovator’ biological, which are approved as ‘New Drugs’. According to the World Health Organization (WHO), these biological products have uncertain safety and efficacy when compared to the reference biological and are therefore not recommended for use. However, these so-called non-innovator biological products continue to be developed in India, for reasons including brief and poorly implemented guidelines on biologicals, a lack of expertise on biosimilars amongst drug regulatory committees, lack of coordination among government departments working on biosimilars, poor quality accreditation in testing laboratories, and a lack of patent protection for innovator drugs. There is an urgent need to identify deficiencies in the ministries responsible for biosimilars in India, which could be through a scientific audit. Compliance with such an audit could strengthen the Indian regulatory system and thus increase the provision of affordable, high quality biosimilars in India.
{"title":"Overview of non-innovator biological products in India","authors":"G. R. Soni","doi":"10.5639/gabij.2020.0901.006","DOIUrl":"https://doi.org/10.5639/gabij.2020.0901.006","url":null,"abstract":"As per regulatory requirements, biosimilar drugs must show high similarity to their reference product in quality, preclinical and clinical tests. It is by these means that biosimilars are considered to be safe and efficacious. In India, any major deviation(s) from science-based principles in the manufacturing of a recombinant DNA-derived therapeutic biological product leads to its classification as a ‘non-innovator’ biological, which are approved as ‘New Drugs’. According to the World Health Organization (WHO), these biological products have uncertain safety and efficacy when compared to the reference biological and are therefore not recommended for use. However, these so-called non-innovator biological products continue to be developed in India, for reasons including brief and poorly implemented guidelines on biologicals, a lack of expertise on biosimilars amongst drug regulatory committees, lack of coordination among government departments working on biosimilars, poor quality accreditation in testing laboratories, and a lack of patent protection for innovator drugs. There is an urgent need to identify deficiencies in the ministries responsible for biosimilars in India, which could be through a scientific audit. Compliance with such an audit could strengthen the Indian regulatory system and thus increase the provision of affordable, high quality biosimilars in India.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89732420","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 : 2020-03-15DOI: 10.5639/gabij.2020.0901.002
Shon Crampton, A. Polozova, Darin Asbury, Alexis M K Lueras, P. Breslin, J. Hippenmeyer, J. Litowski, Monica Goss
Volume 9 | 2020 | Issue 1 | 5 Author for correspondence: Shon Crampton, BA, Scientist, Amgen Inc, 360 Binney Street, Cambridge, MA 02142, USA
第9卷| 2020 |第1期| 5通信作者:Shon Crampton, BA, Scientist, Amgen Inc, 360 Binney Street, Cambridge, MA 02142, USA
{"title":"Stability of the trastuzumab biosimilar ABP 980 compared to reference product after intravenous bag preparation, transport and storage at various temperatures, concentrations and stress conditions","authors":"Shon Crampton, A. Polozova, Darin Asbury, Alexis M K Lueras, P. Breslin, J. Hippenmeyer, J. Litowski, Monica Goss","doi":"10.5639/gabij.2020.0901.002","DOIUrl":"https://doi.org/10.5639/gabij.2020.0901.002","url":null,"abstract":"Volume 9 | 2020 | Issue 1 | 5 Author for correspondence: Shon Crampton, BA, Scientist, Amgen Inc, 360 Binney Street, Cambridge, MA 02142, USA","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89197446","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 : 2020-03-15DOI: 10.5639/gabij.2020.0901.003
A. Alrasheedy
Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable prices. The aim of this study was to provide an overview of the current pharmaceutical pricing policy for medicines in Saudi Arabia and to provide an evaluation of the impact of this policy on medicine prices. Methods: A description of the current pharmaceutical policy is presented by reviewing the current official documents and regulations related to pharmaceutical pricing in Saudi Arabia. A price comparison between the original brand medicines and their generic versions was conducted for the top six selling medicines in Saudi Arabia during the period of 2010–2015. Results: The findings showed that Saudi pharmaceutical pricing policy takes into consideration several factors including an international price benchmark, internal price referencing, and the price of the medicine in the country of origin when determining medicine prices. Based on this policy, there were large differences in the prices of generic medicines compared to original brand medicines. The generic medicine to original brand medicine price ratio was 0.87–0.30. However, the price of the first generic medicine was close to the price of original brand medicine, with the first generic medicine-to-original brand medicine price ratio was 0.87–0.81. In this study, there were large differences in the prices of generic medicines for the same molecule. In fact, price ratio among the generic medicines for the same molecule was between 0.96 and 0.18. However, some generic medicines imported from high income countries were cheaper than the medicines manufactured locally or manufactured in other countries in the Middle East. Conclusion: Medicine prices are strictly controlled through the pharmaceutical pricing policy in Saudi Arabia. Overall, the current policy has resulted in significant price differences among medicines, including medicines of the same molecule. Due to this large difference, the cost savings will depend on the product prescribed or procured by the health organization.
{"title":"Pharmaceutical pricing policy in Saudi Arabia: findings and implications","authors":"A. Alrasheedy","doi":"10.5639/gabij.2020.0901.003","DOIUrl":"https://doi.org/10.5639/gabij.2020.0901.003","url":null,"abstract":"Introduction: Many countries have introduced policies and strategies to limit pharmaceutical expenditures. These include pharmaceutical pricing policies and related strategies to control medicine prices and to ensure appropriate and stable prices. The aim of this study was to provide an overview of the current pharmaceutical pricing policy for medicines in Saudi Arabia and to provide an evaluation of the impact of this policy on medicine prices. Methods: A description of the current pharmaceutical policy is presented by reviewing the current official documents and regulations related to pharmaceutical pricing in Saudi Arabia. A price comparison between the original brand medicines and their generic versions was conducted for the top six selling medicines in Saudi Arabia during the period of 2010–2015. Results: The findings showed that Saudi pharmaceutical pricing policy takes into consideration several factors including an international price benchmark, internal price referencing, and the price of the medicine in the country of origin when determining medicine prices. Based on this policy, there were large differences in the prices of generic medicines compared to original brand medicines. The generic medicine to original brand medicine price ratio was 0.87–0.30. However, the price of the first generic medicine was close to the price of original brand medicine, with the first generic medicine-to-original brand medicine price ratio was 0.87–0.81. In this study, there were large differences in the prices of generic medicines for the same molecule. In fact, price ratio among the generic medicines for the same molecule was between 0.96 and 0.18. However, some generic medicines imported from high income countries were cheaper than the medicines manufactured locally or manufactured in other countries in the Middle East. Conclusion: Medicine prices are strictly controlled through the pharmaceutical pricing policy in Saudi Arabia. Overall, the current policy has resulted in significant price differences among medicines, including medicines of the same molecule. Due to this large difference, the cost savings will depend on the product prescribed or procured by the health organization.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75378560","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 : 2020-03-15DOI: 10.5639/gabij.2020.0901.001
P. Walson
{"title":"Editor’s introduction to the initial issue of the ninth volume of GaBI Journal","authors":"P. Walson","doi":"10.5639/gabij.2020.0901.001","DOIUrl":"https://doi.org/10.5639/gabij.2020.0901.001","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76183300","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 : 2020-03-15DOI: 10.5639/gabij.2020.0901.004
P. Malherbe
Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical need, cost-benefit analysis and insight into the potential for cost reduction through biosimilar competition.
{"title":"An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa","authors":"P. Malherbe","doi":"10.5639/gabij.2020.0901.004","DOIUrl":"https://doi.org/10.5639/gabij.2020.0901.004","url":null,"abstract":"Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical need, cost-benefit analysis and insight into the potential for cost reduction through biosimilar competition.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74116887","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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