Pub Date : 2017-10-30DOI: 10.1136/conmed-2017-100004
T. Dörner, J. Isaacs, J. Gonçalves, V. Azevedo, G. Castañeda-Hernández, R. Strohal, I. McInnes
As of mid-2017, 10 tumour necrosis factor inhibitors (four for etanercept and three each for adalimumab and infliximab) and a first rituximab biosimilar are on the market, and a considerable number more are in various stages of development. The clinical trials of biosimilars, which have included long term extensions, have used various designs to look at switching between originator and biosimilar products, with reassuring results for clinical practice. For the infliximab biosimilar CT-P13 in particular, several studies have examined non-medical switching in real world practice. The results suggest that switching does not compromise safety, efficacy, or immunogenicity. However, additional data from clinical and real world switching studies, especially of switching between two or more biosimilars, are needed, as is continuing pharmacovigilance with larger databases to fill remaining gaps in the evidence. As biosimilar development continues, innovations in formulation and drug delivery technology may become of increasing interest.
{"title":"Biosimilars already approved and in development","authors":"T. Dörner, J. Isaacs, J. Gonçalves, V. Azevedo, G. Castañeda-Hernández, R. Strohal, I. McInnes","doi":"10.1136/conmed-2017-100004","DOIUrl":"https://doi.org/10.1136/conmed-2017-100004","url":null,"abstract":"As of mid-2017, 10 tumour necrosis factor inhibitors (four for etanercept and three each for adalimumab and infliximab) and a first rituximab biosimilar are on the market, and a considerable number more are in various stages of development. The clinical trials of biosimilars, which have included long term extensions, have used various designs to look at switching between originator and biosimilar products, with reassuring results for clinical practice. For the infliximab biosimilar CT-P13 in particular, several studies have examined non-medical switching in real world practice. The results suggest that switching does not compromise safety, efficacy, or immunogenicity. However, additional data from clinical and real world switching studies, especially of switching between two or more biosimilars, are needed, as is continuing pharmacovigilance with larger databases to fill remaining gaps in the evidence. As biosimilar development continues, innovations in formulation and drug delivery technology may become of increasing interest.","PeriodicalId":356175,"journal":{"name":"Considerations in Medicine","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115496187","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 : 2017-10-30DOI: 10.1136/CONMED-2017-100002
I. McInnes
With the projected expansion of the biosimilars market, clinicians must assimilate many important issues. These include understanding biosimilar development, building strategies for biosimilar introduction, and developing robust systems for biosimilar pharmacovigilance. With ten tumour necrosis factor inhibitors, a first rituximab biosimilar now on the market, and many more biosimilars currently in development, controversial issues such as multiple biosimilar switching and indication extrapolation also require consideration. In ‘ The Biosimilar Approval Process: How different is it ?’, Isaacs et al explore the sophisticated biosimilar manufacturing process and the regulatory requirements for …
{"title":"Considering biosimilars in inflammatory diseases","authors":"I. McInnes","doi":"10.1136/CONMED-2017-100002","DOIUrl":"https://doi.org/10.1136/CONMED-2017-100002","url":null,"abstract":"With the projected expansion of the biosimilars market, clinicians must assimilate many important issues. These include understanding biosimilar development, building strategies for biosimilar introduction, and developing robust systems for biosimilar pharmacovigilance. With ten tumour necrosis factor inhibitors, a first rituximab biosimilar now on the market, and many more biosimilars currently in development, controversial issues such as multiple biosimilar switching and indication extrapolation also require consideration.\u0000\u0000In ‘ The Biosimilar Approval Process: How different is it ?’, Isaacs et al explore the sophisticated biosimilar manufacturing process and the regulatory requirements for …","PeriodicalId":356175,"journal":{"name":"Considerations in Medicine","volume":"11 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115899920","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 : 2017-10-30DOI: 10.1136/conmed-2017-100005
V. Azevedo, T. Dörner, R. Strohal, J. Isaacs, G. Castañeda-Hernández, J. Gonçalves, I. McInnes
With the projected expansion of the biosimilars market, there will be an increased propensity for the substitution of reference biological products with cheaper biosimilars for economic reasons (ie, non-medical switching). This will lower the cost per patient and should provide the benefit of wider access to biological therapies. However, it is essential that patients and clinicians fully understand the rationale for non-medical switching and its potential implications in terms of efficacy, safety, and immunogenicity. To date, clinical experience supports the use of biosimilars and a growing body of evidence from clinical trials and real world observational studies specifically supports clinical decision making around non-medical switching. Equally, as non-medical switching becomes more common, it is essential that pharmacovigilance systems adapt to handle the increasing volumes of data needed to effectively monitor the use of biosimilars and detect new signals. This will require a reduced reliance on registries, as well as streamlining and integration of existing systems to allow a frequent cycle of online reporting of adverse events by healthcare professionals, analysis by national authorities, and feedback to treating clinicians. This article considers the current use and future uptake of biosimilars from a clinical perspective.
{"title":"Biosimilars: considerations for clinical practice","authors":"V. Azevedo, T. Dörner, R. Strohal, J. Isaacs, G. Castañeda-Hernández, J. Gonçalves, I. McInnes","doi":"10.1136/conmed-2017-100005","DOIUrl":"https://doi.org/10.1136/conmed-2017-100005","url":null,"abstract":"With the projected expansion of the biosimilars market, there will be an increased propensity for the substitution of reference biological products with cheaper biosimilars for economic reasons (ie, non-medical switching). This will lower the cost per patient and should provide the benefit of wider access to biological therapies. However, it is essential that patients and clinicians fully understand the rationale for non-medical switching and its potential implications in terms of efficacy, safety, and immunogenicity. To date, clinical experience supports the use of biosimilars and a growing body of evidence from clinical trials and real world observational studies specifically supports clinical decision making around non-medical switching. Equally, as non-medical switching becomes more common, it is essential that pharmacovigilance systems adapt to handle the increasing volumes of data needed to effectively monitor the use of biosimilars and detect new signals. This will require a reduced reliance on registries, as well as streamlining and integration of existing systems to allow a frequent cycle of online reporting of adverse events by healthcare professionals, analysis by national authorities, and feedback to treating clinicians. This article considers the current use and future uptake of biosimilars from a clinical perspective.","PeriodicalId":356175,"journal":{"name":"Considerations in Medicine","volume":"10 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127149888","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 : 2017-10-30DOI: 10.1136/conmed-2017-100003
J. Isaacs, J. Gonçalves, R. Strohal, G. Castañeda-Hernández, V. Azevedo, T. Dörner, I. McInnes
Biosimilars are biotherapeutic products with similar efficacy, safety, and quality to a licensed bio-originator. Biosimilars include monoclonal antibodies, soluble receptors, growth factors, and hormones. The manufacture of biosimilars is a sophisticated multi-step process; factors at each stage, such as production cell line, culture conditions, and formulation, may each alter the final product through post-translational modifications. A vial of a therapeutic antibody contains multiple species with distinct glycosylation profiles (microheterogeneity), which are responsible, for example, for complement activation, pharmacokinetics, and structural stability. Whereas the focus for the manufacturer of the bio-originator is to show safety and efficacy in clinical trials, biosimilar development focuses predominantly on in-depth analyses to confirm that the product is identical to the originator in terms of structure, composition, and in vitro activity. Therefore, the critical quality attributes of a biological drug that influences clinical safety and efficacy should be carefully assessed. At least one clinical study is required to compare pharmacokinetics of bio-originator and biosimilar, and at least one sufficiently large randomised controlled trial to demonstrate clinical equivalence. Once biosimilarity is confirmed, regulators may allow extrapolation to other licensed bio-originator indications, provided efficacy relies on a similar mechanism of action in each one. Consequently, a biosimilar may be approved in all indications for which the bio-originator has been approved, without multiple clinical trials.
{"title":"The biosimilar approval process: how different is it?","authors":"J. Isaacs, J. Gonçalves, R. Strohal, G. Castañeda-Hernández, V. Azevedo, T. Dörner, I. McInnes","doi":"10.1136/conmed-2017-100003","DOIUrl":"https://doi.org/10.1136/conmed-2017-100003","url":null,"abstract":"Biosimilars are biotherapeutic products with similar efficacy, safety, and quality to a licensed bio-originator. Biosimilars include monoclonal antibodies, soluble receptors, growth factors, and hormones. The manufacture of biosimilars is a sophisticated multi-step process; factors at each stage, such as production cell line, culture conditions, and formulation, may each alter the final product through post-translational modifications. A vial of a therapeutic antibody contains multiple species with distinct glycosylation profiles (microheterogeneity), which are responsible, for example, for complement activation, pharmacokinetics, and structural stability. Whereas the focus for the manufacturer of the bio-originator is to show safety and efficacy in clinical trials, biosimilar development focuses predominantly on in-depth analyses to confirm that the product is identical to the originator in terms of structure, composition, and in vitro activity. Therefore, the critical quality attributes of a biological drug that influences clinical safety and efficacy should be carefully assessed. At least one clinical study is required to compare pharmacokinetics of bio-originator and biosimilar, and at least one sufficiently large randomised controlled trial to demonstrate clinical equivalence. Once biosimilarity is confirmed, regulators may allow extrapolation to other licensed bio-originator indications, provided efficacy relies on a similar mechanism of action in each one. Consequently, a biosimilar may be approved in all indications for which the bio-originator has been approved, without multiple clinical trials.","PeriodicalId":356175,"journal":{"name":"Considerations in Medicine","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129577301","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 : 2017-10-30DOI: 10.1136/conmed-2017-100006
G. Castañeda-Hernández, R. Strohal, J. Gonçalves, T. Dörner, V. Azevedo, J. Isaacs, I. McInnes
With the authorisation of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Current naming policies are not universal; neither are extrapolation criteria. Indeed, consideration of whether we can extrapolate information from one indication or disease to another continues to be a divisive topic. However, this is changing, as we strive for a more harmonised approach. Such a unified approach will be needed when considering future strategies to follow for multiple biosimilar switching, especially so because there is currently no uniform policy regarding interchangeability, switching, and automatic substitution. In this multiple biosimilar setting, the question as to whether we can be confident to move across indications will be increasingly important. The cost of biosimilar switching also needs to be considered—biosimilar use may mean that patients need more training and medical visits, with associated administrative costs. The biosimilars debate seems to be refocusing issues that have previously been extensively discussed but that have recently lost impetus, including the role of clinical pharmacology in internal medicine.
{"title":"Considering biosimilar policy","authors":"G. Castañeda-Hernández, R. Strohal, J. Gonçalves, T. Dörner, V. Azevedo, J. Isaacs, I. McInnes","doi":"10.1136/conmed-2017-100006","DOIUrl":"https://doi.org/10.1136/conmed-2017-100006","url":null,"abstract":"With the authorisation of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Current naming policies are not universal; neither are extrapolation criteria. Indeed, consideration of whether we can extrapolate information from one indication or disease to another continues to be a divisive topic. However, this is changing, as we strive for a more harmonised approach. Such a unified approach will be needed when considering future strategies to follow for multiple biosimilar switching, especially so because there is currently no uniform policy regarding interchangeability, switching, and automatic substitution. In this multiple biosimilar setting, the question as to whether we can be confident to move across indications will be increasingly important. The cost of biosimilar switching also needs to be considered—biosimilar use may mean that patients need more training and medical visits, with associated administrative costs. The biosimilars debate seems to be refocusing issues that have previously been extensively discussed but that have recently lost impetus, including the role of clinical pharmacology in internal medicine.","PeriodicalId":356175,"journal":{"name":"Considerations in Medicine","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2017-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128467560","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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