Pub Date : 2020-09-15DOI: 10.5639/gabij.2020.0903.020
M. Feldman, M. Reilly
Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars of 15 originator biological medicines have a marketing authorization in Europe. Now, for the second time, the Alliance for Safe Biologic Medicines (ASBM) asked European prescribers for their views on the prescribing, adverse drug reaction reporting, automatic substitution and switching of biologicals and biosimilars. Methods: In March 2019, the ASBM surveyed 579 prescribers in France, Germany, Italy, Spain, Switzerland and the UK. Prescribers were asked for their views on authority over prescribing and dispensing of biologicals/biosimilars, reporting biological/biosimilar use and adverse drug reactions (ADR) and switching. There were also questions related to their familiarity with, knowledge of, attitudes to, and beliefs in, biosimilars. Results: Since the previous European prescriber study conducted in 2013, the percentage of respondents considering themselves highly familiar with biosimilar medicines has increased from 76% to 90%. Four out of five prescribers said they are legally required to report ADR that are brought to their attention and they file detailed ADR reports taking 10‒20 minutes. Four out of five prescribers feel very strongly about having control over what is prescribed and dispensed to their patients. While highly comfortable prescribing biosimilars to naïve patients, physician comfort level decreased when switching a stable patient to a biosimilar. Comfort level decreased further when prescribers were asked about switching a patient to a biosimilar for non-medical reasons, e.g. cost, and further still if the switch is initiated by a third party. Conclusion: European physicians have increased their familiarity with biosimilars since the 2013 survey. Physicians increasingly believe they should always have control of treatment decisions including the decision to switch to a biosimilar. It was also highlighted that governments should make multiple therapeutic options available through tenders.
{"title":"European prescribers’ attitudes and beliefs on biologicals prescribing and\u0000 automatic substitution","authors":"M. Feldman, M. Reilly","doi":"10.5639/gabij.2020.0903.020","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.020","url":null,"abstract":"Introduction: The European Union (EU) and the European Medicines Agency (EMA) have\u0000 led the development of a regulatory framework for biosimilars since 2004. By end of\u0000 December 2019, 64 biosimilars of 15 originator biological medicines have a marketing\u0000 authorization in Europe. Now, for the second time, the Alliance for Safe Biologic\u0000 Medicines (ASBM) asked European prescribers for their views on the prescribing, adverse\u0000 drug reaction reporting, automatic substitution and switching of biologicals and\u0000 biosimilars. Methods: In March 2019, the ASBM surveyed 579 prescribers in France,\u0000 Germany, Italy, Spain, Switzerland and the UK. Prescribers were asked for their views on\u0000 authority over prescribing and dispensing of biologicals/biosimilars, reporting\u0000 biological/biosimilar use and adverse drug reactions (ADR) and switching. There were\u0000 also questions related to their familiarity with, knowledge of, attitudes to, and\u0000 beliefs in, biosimilars. Results: Since the previous European prescriber study conducted\u0000 in 2013, the percentage of respondents considering themselves highly familiar with\u0000 biosimilar medicines has increased from 76% to 90%. Four out of five prescribers said\u0000 they are legally required to report ADR that are brought to their attention and they\u0000 file detailed ADR reports taking 10‒20 minutes. Four out of five prescribers feel very\u0000 strongly about having control over what is prescribed and dispensed to their patients.\u0000 While highly comfortable prescribing biosimilars to naïve patients, physician comfort\u0000 level decreased when switching a stable patient to a biosimilar. Comfort level decreased\u0000 further when prescribers were asked about switching a patient to a biosimilar for\u0000 non-medical reasons, e.g. cost, and further still if the switch is initiated by a third\u0000 party. Conclusion: European physicians have increased their familiarity with biosimilars\u0000 since the 2013 survey. Physicians increasingly believe they should always have control\u0000 of treatment decisions including the decision to switch to a biosimilar. It was also\u0000 highlighted that governments should make multiple therapeutic options available through\u0000 tenders.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79337357","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 : 2020-09-15DOI: 10.5639/gabij.2020.0903.021
Karsten Roth, H. Wessels, J. Hoefler, U. Scholz, Dirk Lehnick
Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with marketing beginning in January 2019. A comprehensive analytical, functional and preclinical comparability programme demonstrated a high degree of similarity between Pelmeg® and its reference product Neulasta®. A targeted clinical development programme was conducted with Pelmeg®, consisting of two comparative pharmacokinetic (PK)/pharmacodynamic (PD) studies in healthy subjects. Since a surrogate endpoint for efficacy (absolute neutrophil count [ANC]) was available, efficacy and safety studies in patients were waived by the regulatory authorities. Clinical studies with Pelmeg® were designed in close dialogue with regulatory authorities in Europe. During the development process for Pelmeg®, the EU biosimilar guidelines, in particular relating to granulocyte colony-stimulating factor (G-CSF), were modified. The development of Pelmeg® demonstrates that regular discussions with regulators, in the form of scientific advice or other interactions, are valuable opportunities for dialogue regarding scientific progress related to the comparability of biosimilars. Regulators – at least in the area of biosimilar development – were found to be open to improvements and to deviate from existing guidelines if there was agreement that the scientific state-of-the-art has superseded some aspect of the guidelines. Overall, we suggest that abridged development programmes waiving the need for phase III studies, as described for Pelmeg®, are possible, in particular if good surrogate endpoints are available. In line with this, the number of waivers for phase III studies in biosimilar development has increased in recent years.
{"title":"Pelmeg®, a biosimilar pegfilgrastim developed in the context of evolving regulatory guidelines","authors":"Karsten Roth, H. Wessels, J. Hoefler, U. Scholz, Dirk Lehnick","doi":"10.5639/gabij.2020.0903.021","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.021","url":null,"abstract":"Pelmeg® is a biosimilar pegfilgrastim, which obtained European Union (EU) regulatory approval in September 2018, with marketing beginning in January 2019. A comprehensive analytical, functional and preclinical comparability programme demonstrated a high degree of similarity between Pelmeg® and its reference product Neulasta®. A targeted clinical development programme was conducted with Pelmeg®, consisting of two comparative pharmacokinetic (PK)/pharmacodynamic (PD) studies in healthy subjects. Since a surrogate endpoint for efficacy (absolute neutrophil count [ANC]) was available, efficacy and safety studies in patients were waived by the regulatory authorities. Clinical studies with Pelmeg® were designed in close dialogue with regulatory authorities in Europe. During the development process for Pelmeg®, the EU biosimilar guidelines, in particular relating to granulocyte colony-stimulating factor (G-CSF), were modified. The development of Pelmeg® demonstrates that regular discussions with regulators, in the form of scientific advice or other interactions, are valuable opportunities for dialogue regarding scientific progress related to the comparability of biosimilars. Regulators – at least in the area of biosimilar development – were found to be open to improvements and to deviate from existing guidelines if there was agreement that the scientific state-of-the-art has superseded some aspect of the guidelines. Overall, we suggest that abridged development programmes waiving the need for phase III studies, as described for Pelmeg®, are possible, in particular if good surrogate endpoints are available. In line with this, the number of waivers for phase III studies in biosimilar development has increased in recent years.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84489312","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 : 2020-09-15DOI: 10.5639/gabij.2020.0903.022
J. Borg, Yolanda Elias Gramajo, A. Laslop, R. Thorpe, Jian Wang
Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia implemented biosimilars regulation in 2017 and a 3rd Colombian Educational Workshop was organized by GaBI and the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in 2019 to follow up on progress and provide a forum for further discussion. Methods: The 3rd Colombian Educational Workshop on Regulatory Assessment was held in Bogotá, Colombia on 30 April 2019. The format included expert speaker presentations, a panel discussion, Q&A sessions and case study workgroup discussions. Participants included regulators, clinicians, pharmacists, academics and healthcare professionals from Colombia who are involved in biological/ biosimilar medicines evaluation, and expert speakers from Canada, Europe and the US. Results: Presentations and topics of discussion included the current status of biosimilars regulation in Colombia, how to carry out a quality assessment of a biological/biosimilar, pharmacological and clinical studies, and extrapolation of indications. Conclusion: The meeting helped to clarify many regulatory concepts and concerns, and highlighted Colombia’s initial successes since the implementation of its regulatory guidelines. In addition, the meeting acted as a forum to exchange knowledge on best practice, and to discuss pharmacovigilance and the future plans for education regarding biosimilars in Colombia. Several key action points were concluded following the discussions.
{"title":"3rd Colombian educational workshop on regulatory assessment of biosimilars 2019 –\u0000 Report","authors":"J. Borg, Yolanda Elias Gramajo, A. Laslop, R. Thorpe, Jian Wang","doi":"10.5639/gabij.2020.0903.022","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.022","url":null,"abstract":"Introduction: Biosimilars have the potential to improve access to medicines for\u0000 many across the globe. However, work is required to ensure adequate regulation,\u0000 pharmacovigilance and education about biosimilars. Colombia implemented biosimilars\u0000 regulation in 2017 and a 3rd Colombian Educational Workshop was organized by GaBI and\u0000 the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in 2019 to\u0000 follow up on progress and provide a forum for further discussion. Methods: The 3rd\u0000 Colombian Educational Workshop on Regulatory Assessment was held in Bogotá, Colombia on\u0000 30 April 2019. The format included expert speaker presentations, a panel discussion,\u0000 Q&A sessions and case study workgroup discussions. Participants included regulators,\u0000 clinicians, pharmacists, academics and healthcare professionals from Colombia who are\u0000 involved in biological/ biosimilar medicines evaluation, and expert speakers from\u0000 Canada, Europe and the US. Results: Presentations and topics of discussion included the\u0000 current status of biosimilars regulation in Colombia, how to carry out a quality\u0000 assessment of a biological/biosimilar, pharmacological and clinical studies, and\u0000 extrapolation of indications. Conclusion: The meeting helped to clarify many regulatory\u0000 concepts and concerns, and highlighted Colombia’s initial successes since the\u0000 implementation of its regulatory guidelines. In addition, the meeting acted as a forum\u0000 to exchange knowledge on best practice, and to discuss pharmacovigilance and the future\u0000 plans for education regarding biosimilars in Colombia. Several key action points were\u0000 concluded following the discussions.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82812830","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 : 2020-09-15DOI: 10.5639/gabij.2020.0903.017
E. Griffiths
Regulatory standards for rDNA derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly effective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support in dealing with these highly complex products. This Commentary highlights the need for regulatory convergence and support, notes the critical role of GMP and draws attention to the comprehensive review by Sia Chong Hock et al. which strongly advocates improving harmonization of regulatory efforts especially in the Association of South East Asian Nations (ASEAN).
{"title":"Quality standards for biopharmaceuticals: the importance of good manufacturing\u0000 practice","authors":"E. Griffiths","doi":"10.5639/gabij.2020.0903.017","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.017","url":null,"abstract":"Regulatory standards for rDNA derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly effective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support in dealing with these highly complex products. This Commentary highlights the need for regulatory convergence and support, notes the critical role of GMP and draws attention to the comprehensive review by Sia Chong Hock et al. which strongly advocates improving harmonization of regulatory efforts especially in the Association of South East Asian Nations (ASEAN).","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78290520","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 : 2020-09-15DOI: 10.5639/gabij.2020.0903.018
T. Hibino, Tomohiko Yoshida, A. Sagawa, I. Masuda, T. Fukuda
Study objective: Needle fear is common among patients with rheumatoid arthritis (RA) who require subcutaneous (SC) injections. The convenience, usability and safety of the etanercept biosimilar YLB113 in an injection pen were evaluated among patients who switched from syringe injection. Methods: Patients with RA who had completed the phase III clinical study of YLB113 in a pre-filled syringe (YLB113-002) were enrolled (n = 35) and received once-weekly SC injections with the injection pen (YLB113 50 mg) for 8 weeks. After 8 weeks, patients completed a qualitative survey evaluating the form and design of the pen, its operability, and patient preference for pen or syringe. Adverse events were evaluated throughout the study. Results: Most patients reported the pen was ‘very easy to grasp’ or ‘easy to grasp.’ The pen was also reported to be easy to operate. The click signalling the start and end of the injection could be heard ‘very well’ or ‘well’. Similarly, the injection solution check window could be seen by most patients. About three-quarters of respondents preferred the pen over a syringe. The pen was considered easier to use for the following reasons: the body is easy to grasp; the procedure is easy to understand; and the procedure can be performed without anxiety, fear, or tenseness. Conclusions: The majority of these Japanese subjects with RA in the study judged the YLB113 50 mg delivered by injection pen to be easy to use, convenient and well tolerated
{"title":"Qualitative survey-based evaluation of operability and convenience for the\u0000 etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid\u0000 arthritis","authors":"T. Hibino, Tomohiko Yoshida, A. Sagawa, I. Masuda, T. Fukuda","doi":"10.5639/gabij.2020.0903.018","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.018","url":null,"abstract":"Study objective: Needle fear is common among patients with rheumatoid arthritis\u0000 (RA) who require subcutaneous (SC) injections. The convenience, usability and safety of\u0000 the etanercept biosimilar YLB113 in an injection pen were evaluated among patients who\u0000 switched from syringe injection. Methods: Patients with RA who had completed the phase\u0000 III clinical study of YLB113 in a pre-filled syringe (YLB113-002) were enrolled (n = 35)\u0000 and received once-weekly SC injections with the injection pen (YLB113 50 mg) for 8\u0000 weeks. After 8 weeks, patients completed a qualitative survey evaluating the form and\u0000 design of the pen, its operability, and patient preference for pen or syringe. Adverse\u0000 events were evaluated throughout the study. Results: Most patients reported the pen was\u0000 ‘very easy to grasp’ or ‘easy to grasp.’ The pen was also reported to be easy to\u0000 operate. The click signalling the start and end of the injection could be heard ‘very\u0000 well’ or ‘well’. Similarly, the injection solution check window could be seen by most\u0000 patients. About three-quarters of respondents preferred the pen over a syringe. The pen\u0000 was considered easier to use for the following reasons: the body is easy to grasp; the\u0000 procedure is easy to understand; and the procedure can be performed without anxiety,\u0000 fear, or tenseness. Conclusions: The majority of these Japanese subjects with RA in the\u0000 study judged the YLB113 50 mg delivered by injection pen to be easy to use, convenient\u0000 and well tolerated","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86665148","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 : 2020-09-15DOI: 10.5639/gabij.2020.0903.016
P. Walson
{"title":"Latest features in GaBI Journal, 2020, Issue 3","authors":"P. Walson","doi":"10.5639/gabij.2020.0903.016","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.016","url":null,"abstract":"","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86761979","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 : 2020-09-15DOI: 10.5639/gabij.2020.0903.019
R. Alten, H. Kellner, M. Boyce, Takuma Yonemura, Takahiro Ito, M. Genovese
Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in safety profile, efficacy and immunogenicity. FKB327 formulation excipients differ from the citrate-containing formulation of the reference product, and injection-site pain differences have been reported. The current analysis examines pooled data to assess the amount of injection-site pain resulting from injecting FKB327 using a prefilled syringe, autoinjector, or vial/syringe versus the reference product. Methods: Data from four studies were pooled to compare injection-site pain upon subcutaneous administration of FKB327 versus the reference product. Pooled data were analysed to compare FKB327 with the reference product and to compare the autoinjector, pre-filled syringe and vial/syringe. Results: Data were analysed from 2007 assessments in 1,001 subjects. A linear mixed model of the injection-site pain visual analogue scale score across all studies showed a 12.6-point lower pain score for FKB327 versus the reference product (95% confidence interval, –14.3 to –10.8; p > 0.001). The autoinjector pain score was 4.4 points lower than the vial/syringe (95% confidence interval, –5.9 to –2.8; p > 0.001) and 1.7 points lower than the pre-filled syringe (95% confidence interval, –3.3 to –0.1; p = 0.035). No statistically significant differences were identified for gender, age, body weight, needle gauge, or injection site. Conclusion: FKB327 showed less injection-site pain compared with the reference product. No statistically significant differences were seen in injection-site reactions or related adverse events between FKB327 and the reference product or among FKB327 injection methods.
{"title":"Systematic analysis of injection-site pain and reactions caused by subcutaneous\u0000 administration of the adalimumab biosimilar FKB327 versus the adalimumab reference\u0000 product via different delivery methods","authors":"R. Alten, H. Kellner, M. Boyce, Takuma Yonemura, Takahiro Ito, M. Genovese","doi":"10.5639/gabij.2020.0903.019","DOIUrl":"https://doi.org/10.5639/gabij.2020.0903.019","url":null,"abstract":"Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference\u0000 product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated\u0000 biosimilarity between FKB327 and the reference product in safety profile, efficacy and\u0000 immunogenicity. FKB327 formulation excipients differ from the citrate-containing\u0000 formulation of the reference product, and injection-site pain differences have been\u0000 reported. The current analysis examines pooled data to assess the amount of\u0000 injection-site pain resulting from injecting FKB327 using a prefilled syringe,\u0000 autoinjector, or vial/syringe versus the reference product. Methods: Data from four\u0000 studies were pooled to compare injection-site pain upon subcutaneous administration of\u0000 FKB327 versus the reference product. Pooled data were analysed to compare FKB327 with\u0000 the reference product and to compare the autoinjector, pre-filled syringe and\u0000 vial/syringe. Results: Data were analysed from 2007 assessments in 1,001 subjects. A\u0000 linear mixed model of the injection-site pain visual analogue scale score across all\u0000 studies showed a 12.6-point lower pain score for FKB327 versus the reference product\u0000 (95% confidence interval, –14.3 to –10.8; p > 0.001). The autoinjector pain score was\u0000 4.4 points lower than the vial/syringe (95% confidence interval, –5.9 to –2.8; p >\u0000 0.001) and 1.7 points lower than the pre-filled syringe (95% confidence interval, –3.3\u0000 to –0.1; p = 0.035). No statistically significant differences were identified for\u0000 gender, age, body weight, needle gauge, or injection site. Conclusion: FKB327 showed\u0000 less injection-site pain compared with the reference product. No statistically\u0000 significant differences were seen in injection-site reactions or related adverse events\u0000 between FKB327 and the reference product or among FKB327 injection methods.","PeriodicalId":43994,"journal":{"name":"GaBI Journal-Generics and Biosimilars Initiative Journal","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73500825","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.2020.0902.010
Sia Chong Hock, Sia Ming Kian, Chan Lai Wah
Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. With the patent expiry of the originator biopharmaceuticals, a surge in the production of biopharmaceuticals in the form of biosimilars is to be expected. However, biopharmaceuticals are inherently more complex than conventional chemical-based pharmaceuticals, hence requiring a more complicated manufacturing process. This paper provides a brief overview of the biopharmaceutical manufacturing processes and reveals that most biopharmaceuticals share similar processes and considerations. The complex nature of biopharmaceuticals presents various manufacturing challenges such as the inherent variation in quality and demand for extensive process and product understanding. Furthermore, downstream processing bottleneck also presents another manufacturing challenge. A brief comparison of the good manufacturing practice (GMP) standards of various regulatory authorities (RAs) and international organizations (IOs) reveals that the standards are largely similar and appropriate in addressing the manufacturing challenges. This review is one of the few covering the biopharmaceutical industry and the regulatory framework of the Association of South East Asian Nations (ASEAN). However, GMP alone does not address regulatory challenges such as evaluation of biosimilarity, differing outlook on interchangeability and a growing occurrence of data integrity lapses. Solutions such as the implementation of Industry 4.0, improved harmonization of regulatory efforts and creating a culture of quality within the organization may help to address the forgoing challenges.
{"title":"Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals","authors":"Sia Chong Hock, Sia Ming Kian, Chan Lai Wah","doi":"10.5639/gabij.2020.0902.010","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.010","url":null,"abstract":"Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. With the patent expiry of the originator biopharmaceuticals, a surge in the production of biopharmaceuticals in the form of biosimilars is to be expected. However, biopharmaceuticals are inherently more complex than conventional chemical-based pharmaceuticals, hence requiring a more complicated manufacturing process. This paper provides a brief overview of the biopharmaceutical manufacturing processes and reveals that most biopharmaceuticals share similar processes and considerations. The complex nature of biopharmaceuticals presents various manufacturing challenges such as the inherent variation in quality and demand for extensive process and product understanding. Furthermore, downstream processing bottleneck also presents another manufacturing challenge. A brief comparison of the good manufacturing practice (GMP) standards of various regulatory authorities (RAs) and international organizations (IOs) reveals that the standards are largely similar and appropriate in addressing the manufacturing challenges. This review is one of the few covering the biopharmaceutical industry and the regulatory framework of the Association of South East Asian Nations (ASEAN). However, GMP alone does not address regulatory challenges such as evaluation of biosimilarity, differing outlook on interchangeability and a growing occurrence of data integrity lapses. Solutions such as the implementation of Industry 4.0, improved harmonization of regulatory efforts and creating a culture of quality within the organization may help to address the forgoing challenges.","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":"87952103","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.2020.0902.008
P. Walson
{"title":"What to look forward to in GaBI Journal, 2020, Issue 2","authors":"P. Walson","doi":"10.5639/gabij.2020.0902.008","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.008","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":"83938482","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.2020.0902.011
E. Ortiz-Prado, Jorge Ponce-Zea, J. Vásconez, Diana Castillo, Diana C Checa-Jaramilloz, Nathalia Rodríguez-Burneo, Felipe Andrade, Damaris P Intriago Baldeón, C. Galarza-Maldonado
The number of approved biological medicines in the global pharmaceutical market has increased in recent decades. However, their high costs have also promoted the development of biosimilar medicines, following the expiry of the patent of the reference drug. Biosimilars are approved medicines of biological origin which have no statistically significant differences in terms of quality, safety and therapeutic efficacy in comparison with the reference biological. Drugs marketed as biomimics meanwhile are copies of monoclonal antibodies and fusion proteins that have not demonstrated bioequivalence to their reference biologicals. Across the world, regulations have been developed to ensure the safety and efficacy of biosimilar products, which can reduce public health expenditure and improve patient access to biological medicines. As a result, Latin America has begun to invest in the development of these drugs. The objective of this literature review is to describe the development of the biosimilar and biomimic market in Latin America.
{"title":"Current trends for biosimilars in the Latin American market","authors":"E. Ortiz-Prado, Jorge Ponce-Zea, J. Vásconez, Diana Castillo, Diana C Checa-Jaramilloz, Nathalia Rodríguez-Burneo, Felipe Andrade, Damaris P Intriago Baldeón, C. Galarza-Maldonado","doi":"10.5639/gabij.2020.0902.011","DOIUrl":"https://doi.org/10.5639/gabij.2020.0902.011","url":null,"abstract":"The number of approved biological medicines in the global pharmaceutical market has increased in recent decades. However, their high costs have also promoted the development of biosimilar medicines, following the expiry of the patent of the reference drug. Biosimilars are approved medicines of biological origin which have no statistically significant differences in terms of quality, safety and therapeutic efficacy in comparison with the reference biological. Drugs marketed as biomimics meanwhile are copies of monoclonal antibodies and fusion proteins that have not demonstrated bioequivalence to their reference biologicals. Across the world, regulations have been developed to ensure the safety and efficacy of biosimilar products, which can reduce public health expenditure and improve patient access to biological medicines. As a result, Latin America has begun to invest in the development of these drugs. The objective of this literature review is to describe the development of the biosimilar and biomimic market in Latin America.","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":"85270292","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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