Pub Date : 2021-03-15DOI: 10.5639/GABIJ.2021.1001.003
M. Zargaran, A. Cheraghali, F. Soleymani, Rajabali Daroudi, A. Sari, S. Nikfar
Background: Enacting national policies which empower the local production of medications is a promising way to improve the accessibility and affordability of medications, but this can also have unintended consequences. A number of such policies have been adopted by the Iranian government. This study was designed to examine the changes in the consumption of a number of selected pharmaceuticals which occurred in the years after these selected products began to be domestically produced. The implications of these changes were then evaluated for their potential to suggest possible policy changes. Method: A 10-year trend study was conducted to identify changes which occurred between 2007 and 2017 in the consumption of 28 selected, imported medications after they began to be domestically produced. Results: Six different medication consumption patterns were observed after the development of domestic medication production. In addition, a downward trend in the cost of medications was observed, specifically due to the introduction of domestic pharmaceuticals. Discussion: Examination of the observed changes in the consumption patterns revealed that various factors affect consumption patterns of imported medications. Significant increases in certain domestically manufactured medications indicated that local production might result in the irrational use of medications. In addition, the competitiveness of Iranian products, in terms of quality and accessibility should be considered. Conclusion: New considerations are needed for health policymakers to support domestic production of viable alternative medications. However, increased accessibility of domestically produced medications may result in greater unreasonable use of medications
{"title":"An assessment of trends in the Iranian pharmaceutical market following domestic production of selected medications (2007‒2017) and new considerations for health policymakers","authors":"M. Zargaran, A. Cheraghali, F. Soleymani, Rajabali Daroudi, A. Sari, S. Nikfar","doi":"10.5639/GABIJ.2021.1001.003","DOIUrl":"https://doi.org/10.5639/GABIJ.2021.1001.003","url":null,"abstract":"Background: Enacting national policies which empower the local production of medications is a promising way to improve the accessibility and affordability of medications, but this can also have unintended consequences. A number of such policies have been adopted by the Iranian government. This study was designed to examine the changes in the consumption of a number of selected pharmaceuticals which occurred in the years after these selected products began to be domestically produced. The implications of these changes were then evaluated for their potential to suggest possible policy changes. Method: A 10-year trend study was conducted to identify changes which occurred between 2007 and 2017 in the consumption of 28 selected, imported medications after they began to be domestically produced. Results: Six different medication consumption patterns were observed after the development of domestic medication production. In addition, a downward trend in the cost of medications was observed, specifically due to the introduction of domestic pharmaceuticals. Discussion: Examination of the observed changes in the consumption patterns revealed that various factors affect consumption patterns of imported medications. Significant increases in certain domestically manufactured medications indicated that local production might result in the irrational use of medications. In addition, the competitiveness of Iranian products, in terms of quality and accessibility should be considered. Conclusion: New considerations are needed for health policymakers to support domestic production of viable alternative medications. However, increased accessibility of domestically produced medications may result in greater unreasonable use of medications","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80599245","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 : 2021-03-15DOI: 10.5639/GABIJ.2021.1001.004
Sia Chong Hock, Teh Kee Siang, Chan Lai Wah
Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals has transformed from buzzword to reality, with at least eight currently approved drugs produced by CM. Propelled by various driving forces, manufacturers and regulators have recognized the benefits of CM and are awaiting the completion of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13, a harmonized guideline on CM that would be implemented by ICH members. Although significant progress is evident, the uptake of CM is still sluggish in the pharmaceutical industry due to many existing challenges that have hindered manufacturers from adopting this technology. The top two barriers that manufacturers currently face are regulatory uncertainties and high initial cost. These issues are crucial in unleashing the untapped potential of CM, which has significant implications on patients’ access to life-saving medicines, while mutually benefitting manufacturers and regulators. Despite numerous studies, there have been few existing publications that review current regulatory guidelines, highlight the latest challenges extensively and propose recommendations that are applicable for all pharmaceuticals and biopharmaceuticals. Therefore, this critical review aims to present the recent progress and existing challenges to provide greater clarity for manufacturers on CM. This review also proposes vital recommendations and future perspectives. These include regulatory harmonization, managing financial risks, hybrid processes, capacity building, a culture of quality and Pharma 4.0. While regulators and the industry work towards creating a harmonized guideline on CM, manufacturers should focus on overcoming existing cost, technical and cultural challenges to facilitate the implementation of CM.
{"title":"Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators","authors":"Sia Chong Hock, Teh Kee Siang, Chan Lai Wah","doi":"10.5639/GABIJ.2021.1001.004","DOIUrl":"https://doi.org/10.5639/GABIJ.2021.1001.004","url":null,"abstract":"Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals has transformed from buzzword to reality, with at least eight currently approved drugs produced by CM. Propelled by various driving forces, manufacturers and regulators have recognized the benefits of CM and are awaiting the completion of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q13, a harmonized guideline on CM that would be implemented by ICH members. Although significant progress is evident, the uptake of CM is still sluggish in the pharmaceutical industry due to many existing challenges that have hindered manufacturers from adopting this technology. The top two barriers that manufacturers currently face are regulatory uncertainties and high initial cost. These issues are crucial in unleashing the untapped potential of CM, which has significant implications on patients’ access to life-saving medicines, while mutually benefitting manufacturers and regulators. Despite numerous studies, there have been few existing publications that review current regulatory guidelines, highlight the latest challenges extensively and propose recommendations that are applicable for all pharmaceuticals and biopharmaceuticals. Therefore, this critical review aims to present the recent progress and existing challenges to provide greater clarity for manufacturers on CM. This review also proposes vital recommendations and future perspectives. These include regulatory harmonization, managing financial risks, hybrid processes, capacity building, a culture of quality and Pharma 4.0. While regulators and the industry work towards creating a harmonized guideline on CM, manufacturers should focus on overcoming existing cost, technical and cultural challenges to facilitate the implementation of CM.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86419784","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 : 2021-02-03DOI: 10.5639/gabij.2021.1002.008
B. Godman, S. Simoens, A. Kurdi, G. Selke, J. Yfantopoulos, A. Hill, J. Gulbinovič, A. Martin, A. Timoney, D. Gotham, J. Wale, T. Bochenek, I. Krulichová, E. Allocati, Iris Hoxha, Admir Malaj, Christian Hierländer, A. Nachtnebel, W. Hamelinck, Z. Mitkova, G. Petrova, O. Laius, C. Sermet, Irene Langner, R. Joppi, A. Jakupi, E. Poplavska, Ieva Greičiūtė-Kuprijanov, P. V. Bonanno, Hans Piepenbrink, V. D. Valk, R. Plisko, M. Władysiuk, Vanda Marković-Peković, I. Mardare, T. Novakovic, M. Parker, Jurij Fürst, D Tomek, K. Baňasová, Merce Obach Cortadellas, Corrine Zara, C. Pontes, Maria Juhasz-Haverinen, Peter Skiold, S. McTaggart, D. Wong-Rieger, Stephen M Campbell, R. Hill
Introduction/Objectives: Health authorities are facing increasing challenges to the sustainability of their healthcare systems because of the growing expenditures on medicines, including new, high-priced oncology medicines, and changes in disease prevalence in their ageing populations. Medicine prices in European countries are greatly affected by the ability to negotiate reasonable prices. Concerns have been expressed that prices of patented medicines do not fall sufficiently after the introduction of lower-cost generic oncology medicines. The objective of this study was to examine the associations over time in selected European countries between the prices of oral oncology medicines, population size, and gross domestic product (GDP) before and after the introduction of generic versions. Evidence of periodic reassessments of the price, value, and place in treatment of these medicines was also looked for. The goal of this review was to stimulate debate about possible improvements in approaches to reimbursement negotiations. Methodology: Analysis was performed of reimbursed prices of three oral oncology medicines (imatinib, erlotinib and fludarabine) between 2013 and 2017 across Europe. Correlations were explored between GDP, population size, and prices. Findings were compared with previous research regarding prices of generic oral oncology medicines. Results: The prices of imatinib, erlotinib and fludarabine varied among European countries, and there was limited price erosion over time in the absence of generics. There appeared to be no correlation between population size and price, but higher prices of on-patent oral cancer medicines were seen among countries with higher GDP per capita. Conclusion: Limited price erosion for patented medicines contributed to increases in oncology medicine budgets across the region. There was also a concerning lack of evidence re-assessments of the price, value, and place in treatment of patented oncology medicines following the loss of patent protection of standard medicines. The use of such proactive re-assessments in negotiating tactics might positively impact global expenditures for oncology medicines.
{"title":"Variation in the prices of oncology medicines across Europe and the implications for the future","authors":"B. Godman, S. Simoens, A. Kurdi, G. Selke, J. Yfantopoulos, A. Hill, J. Gulbinovič, A. Martin, A. Timoney, D. Gotham, J. Wale, T. Bochenek, I. Krulichová, E. Allocati, Iris Hoxha, Admir Malaj, Christian Hierländer, A. Nachtnebel, W. Hamelinck, Z. Mitkova, G. Petrova, O. Laius, C. Sermet, Irene Langner, R. Joppi, A. Jakupi, E. Poplavska, Ieva Greičiūtė-Kuprijanov, P. V. Bonanno, Hans Piepenbrink, V. D. Valk, R. Plisko, M. Władysiuk, Vanda Marković-Peković, I. Mardare, T. Novakovic, M. Parker, Jurij Fürst, D Tomek, K. Baňasová, Merce Obach Cortadellas, Corrine Zara, C. Pontes, Maria Juhasz-Haverinen, Peter Skiold, S. McTaggart, D. Wong-Rieger, Stephen M Campbell, R. Hill","doi":"10.5639/gabij.2021.1002.008","DOIUrl":"https://doi.org/10.5639/gabij.2021.1002.008","url":null,"abstract":"Introduction/Objectives: Health authorities are facing increasing challenges to the sustainability of their healthcare systems because of the growing expenditures on medicines, including new, high-priced oncology medicines, and changes in disease prevalence in their ageing populations. Medicine prices in European countries are greatly affected by the ability to negotiate reasonable prices. Concerns have been expressed that prices of patented medicines do not fall sufficiently after the introduction of lower-cost generic oncology medicines. The objective of this study was to examine the associations over time in selected European countries between the prices of oral oncology medicines, population size, and gross domestic product (GDP) before and after the introduction of generic versions. Evidence of periodic reassessments of the price, value, and place in treatment of these medicines was also looked for. The goal of this review was to stimulate debate about possible improvements in approaches to reimbursement negotiations. Methodology: Analysis was performed of reimbursed prices of three oral oncology medicines (imatinib, erlotinib and fludarabine) between 2013 and 2017 across Europe. Correlations were explored between GDP, population size, and prices. Findings were compared with previous research regarding prices of generic oral oncology medicines. Results: The prices of imatinib, erlotinib and fludarabine varied among European countries, and there was limited price erosion over time in the absence of generics. There appeared to be no correlation between population size and price, but higher prices of on-patent oral cancer medicines were seen among countries with higher GDP per capita. Conclusion: Limited price erosion for patented medicines contributed to increases in oncology medicine budgets across the region. There was also a concerning lack of evidence re-assessments of the price, value, and place in treatment of patented oncology medicines following the loss of patent protection of standard medicines. The use of such proactive re-assessments in negotiating tactics might positively impact global expenditures for oncology medicines.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82272934","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 : 2020-12-15DOI: 10.5639/GABIJ.2020.0904.024
A. Astier
This editorial highlights the importance of carrying out comparative studies of patient tolerance to biosimilars and originator products. Minor side effects can affect their acceptability.
{"title":"Is the local tolerance of injectable biosimilars too underestimated?","authors":"A. Astier","doi":"10.5639/GABIJ.2020.0904.024","DOIUrl":"https://doi.org/10.5639/GABIJ.2020.0904.024","url":null,"abstract":"This editorial highlights the importance of carrying out comparative studies of patient tolerance to biosimilars and originator products. Minor side effects can affect their acceptability.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81792454","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 : 2020-12-15DOI: 10.5639/GABIJ.2020.0904.023
P. Walson
{"title":"Medical journal publication during global stress","authors":"P. Walson","doi":"10.5639/GABIJ.2020.0904.023","DOIUrl":"https://doi.org/10.5639/GABIJ.2020.0904.023","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"91305715","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 : 2020-12-15DOI: 10.5639/GABIJ.2020.0904.028
Sia Chong Hock, Vernon Tay, V. Sachdeva, Chan Lai Wah
Data Integrity, which is data deemed Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA-plus), has been the focus of the pharmaceutical industry in recent years. With the growing use of computerized systems and rising prevalence of outsourcing manufacturing processes, ensuring data integrity is becoming more challenging in an increasingly complex pharmaceutical manufacturing industry. To address this issue, multiple legislation and guidance documents such as ‘Data Integrity and Compliance with CGMP Guidance for Industry’ from the US Food and Drug Administration (FDA), ‘GxP’ Data Integrity Guidance and Definitions from the UK Medicines & Healthcare products Regulatory Agency (MHRA), and ‘Guidance on Good Data and Record Management Practices’ from the World Health Organization (WHO), have been published in recent years. However, with rising data integrity issues observed by FDA, WHO, MHRA and other pharmaceutical inspectors even after these guidance documents have been published, their overall effectiveness is yet to be determined. This paper compares and evaluates the legislation and guidance currently in existence; and discusses some of the potential challenges pharmaceutical manufacturers face in maintaining data integrity with such legislation and guidance in place. It appears that these legislation and guidance are insufficient in maintaining data integrity in the industry when used alone. Last, but not least, this paper also reviews other solutions, such as the need for a company culture of integrity, a good database management system, education and training, robust quality agreements between contract givers and acceptors, and performance of effective audits and inspections, to aid in maintaining data integrity in the manufacturing industry. These proposed solutions, if successfully implemented, can address the issues associated with data integrity, and raise the standard of pharmaceutical and biopharmaceutical manufacturing worldwide.
{"title":"Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors","authors":"Sia Chong Hock, Vernon Tay, V. Sachdeva, Chan Lai Wah","doi":"10.5639/GABIJ.2020.0904.028","DOIUrl":"https://doi.org/10.5639/GABIJ.2020.0904.028","url":null,"abstract":"Data Integrity, which is data deemed Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA-plus), has been the focus of the pharmaceutical industry in recent years. With the growing use of computerized systems and rising prevalence of outsourcing manufacturing processes, ensuring data integrity is becoming more challenging in an increasingly complex pharmaceutical manufacturing industry. To address this issue, multiple legislation and guidance documents such as ‘Data Integrity and Compliance with CGMP Guidance for Industry’ from the US Food and Drug Administration (FDA), ‘GxP’ Data Integrity Guidance and Definitions from the UK Medicines & Healthcare products Regulatory Agency (MHRA), and ‘Guidance on Good Data and Record Management Practices’ from the World Health Organization (WHO), have been published in recent years. However, with rising data integrity issues observed by FDA, WHO, MHRA and other pharmaceutical inspectors even after these guidance documents have been published, their overall effectiveness is yet to be determined. This paper compares and evaluates the legislation and guidance currently in existence; and discusses some of the potential challenges pharmaceutical manufacturers face in maintaining data integrity with such legislation and guidance in place. It appears that these legislation and guidance are insufficient in maintaining data integrity in the industry when used alone. Last, but not least, this paper also reviews other solutions, such as the need for a company culture of integrity, a good database management system, education and training, robust quality agreements between contract givers and acceptors, and performance of effective audits and inspections, to aid in maintaining data integrity in the manufacturing industry. These proposed solutions, if successfully implemented, can address the issues associated with data integrity, and raise the standard of pharmaceutical and biopharmaceutical manufacturing worldwide.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87267431","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 : 2020-12-15DOI: 10.5639/GABIJ.2020.0904.027
A. Bertolani, C. Jommi
Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding prescribing behaviour is limited. Furthermore, there is no evidence on whether local authorities implemented a policy framework aimed to appropriately reallocate resources gained through patent expiration. This paper aims to fill these gaps, investigating policies on biosimilars implemented at the local level in the Italian National Health Service. Materials and Methods: Data were retrieved through a structured, validated questionnaire, administered online to all 199 public HCOs. Results: Seventy-six organizations in 16 of 21 Italian regions completed the survey, 89% of HCOs implemented information/educational initiatives on biosimilars. Prescription targets on biosimilars versus originators and off-patent versus in-patent molecules were introduced in 62% and 75% of HCOs, respectively. Prescribers reaching targets are mostly rewarded through monetary incentives. 75% of HCOs performed systematic impact evaluation of biosimilars. However, only 21% of HCOs detect patient under-treatment due to budget constraints and how availability of cheaper drugs could help. Furthermore, according to 25% of respondents, their HCO is involved in studies on biosimilars, but respondents did not provide any evidence of these studies. Discussion and conclusions: The study shows a high level of proactivity by Italian HCOs regarding actions on prescribing behaviour for off-patent biologicals. However, it seems that structured actions aimed at appropriately reallocating resources gained through patent expiration are still lacking.
{"title":"Local policies on biosimilars: are they designed to optimize use of liberated resources?","authors":"A. Bertolani, C. Jommi","doi":"10.5639/GABIJ.2020.0904.027","DOIUrl":"https://doi.org/10.5639/GABIJ.2020.0904.027","url":null,"abstract":"Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding prescribing behaviour is limited. Furthermore, there is no evidence on whether local authorities implemented a policy framework aimed to appropriately reallocate resources gained through patent expiration. This paper aims to fill these gaps, investigating policies on biosimilars implemented at the local level in the Italian National Health Service. Materials and Methods: Data were retrieved through a structured, validated questionnaire, administered online to all 199 public HCOs. Results: Seventy-six organizations in 16 of 21 Italian regions completed the survey, 89% of HCOs implemented information/educational initiatives on biosimilars. Prescription targets on biosimilars versus originators and off-patent versus in-patent molecules were introduced in 62% and 75% of HCOs, respectively. Prescribers reaching targets are mostly rewarded through monetary incentives. 75% of HCOs performed systematic impact evaluation of biosimilars. However, only 21% of HCOs detect patient under-treatment due to budget constraints and how availability of cheaper drugs could help. Furthermore, according to 25% of respondents, their HCO is involved in studies on biosimilars, but respondents did not provide any evidence of these studies. Discussion and conclusions: The study shows a high level of proactivity by Italian HCOs regarding actions on prescribing behaviour for off-patent biologicals. However, it seems that structured actions aimed at appropriately reallocating resources gained through patent expiration are still lacking.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79009338","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 : 2020-12-15DOI: 10.5639/GABIJ.2020.0904.026
J. Šečkutė, I. Castellanos, S. Bane
Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into intravenous bags, extended storage, and simulated infusion to enable advanced preparation and storage. Methods: Two lots of ABP 215 were diluted to high- (16.5 mg/mL) and low- (1.4 mg/mL) dose concentrations in two types of intravenous bag under ambient light conditions. Dosed intravenous bags were stored at 2°C–8°C for 35 days, followed by 30°C for 2 days, and each bag was infused on Day 37. Analysis of purity and physicochemical stability was performed using size-exclusion high-performance liquid chromatography (SE-HPLC), cation-exchange high-performance liquid chromatography (CEX-HPLC), reduced capillary electrophoresis-sodium dodecyl sulphate (rCE-SDS), subvisible particle detection assays, visual inspection, and by measuring protein concentration and potency. Results: No meaningful changes were seen in ABP 215 purity when analysed by SE-HPLC, CEX-HPLC and rCE-SDS following dilution, storage and infusion of two lots, bags, and doses. Protein concentration remained consistent throughout the study for all samples and no significant loss in potency was detected. No potentially proteinaceous particles or increases in subvisible particles were observed. Discussion: This study investigated the in-use stability of ABP 215 following dilution, extended storage, and infusion, that represent worst-case handling conditions. ABP 215 exhibited consistent product quality and activity, with no significant degradation observed under the conditions tested. Conclusion: ABP 215 retains physicochemical stability after dilution over the recommended dosing concentrations, extended storage, and simulated infusion. This supports the advance preparation and storage of ABP 215 in intravenous bags for infusion.
{"title":"Physicochemical stability of the bevacizumab biosimilar, ABP 215, after preparation and storage in intravenous bags","authors":"J. Šečkutė, I. Castellanos, S. Bane","doi":"10.5639/GABIJ.2020.0904.026","DOIUrl":"https://doi.org/10.5639/GABIJ.2020.0904.026","url":null,"abstract":"Study Objectives: To evaluate extended in-use stability of bevacizumab biosimilar, ABP 215, after dilution into intravenous bags, extended storage, and simulated infusion to enable advanced preparation and storage. Methods: Two lots of ABP 215 were diluted to high- (16.5 mg/mL) and low- (1.4 mg/mL) dose concentrations in two types of intravenous bag under ambient light conditions. Dosed intravenous bags were stored at 2°C–8°C for 35 days, followed by 30°C for 2 days, and each bag was infused on Day 37. Analysis of purity and physicochemical stability was performed using size-exclusion high-performance liquid chromatography (SE-HPLC), cation-exchange high-performance liquid chromatography (CEX-HPLC), reduced capillary electrophoresis-sodium dodecyl sulphate (rCE-SDS), subvisible particle detection assays, visual inspection, and by measuring protein concentration and potency. Results: No meaningful changes were seen in ABP 215 purity when analysed by SE-HPLC, CEX-HPLC and rCE-SDS following dilution, storage and infusion of two lots, bags, and doses. Protein concentration remained consistent throughout the study for all samples and no significant loss in potency was detected. No potentially proteinaceous particles or increases in subvisible particles were observed. Discussion: This study investigated the in-use stability of ABP 215 following dilution, extended storage, and infusion, that represent worst-case handling conditions. ABP 215 exhibited consistent product quality and activity, with no significant degradation observed under the conditions tested. Conclusion: ABP 215 retains physicochemical stability after dilution over the recommended dosing concentrations, extended storage, and simulated infusion. This supports the advance preparation and storage of ABP 215 in intravenous bags for infusion.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73382386","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 : 2020-12-15DOI: 10.5639/GABIJ.2020.0904.025
M. Feldman, M. Reilly
In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.
{"title":"A white paper: US biosimilars market on pace with Europe","authors":"M. Feldman, M. Reilly","doi":"10.5639/GABIJ.2020.0904.025","DOIUrl":"https://doi.org/10.5639/GABIJ.2020.0904.025","url":null,"abstract":"In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76631814","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 : 2020-10-06DOI: 10.5639/GABIJ.2020.0904.029
B. Godman, E. Allocati, Evelien Moorkens, H. Kwon
There is an increasing need to prescribe biosimilars to fund new medicines and increasing medicine volumes. Bertolani and Jommi document successful measures introduced regionally in Italy.
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