Sabrina Rodrigues de Figueiredo, Ana Elisa Rabe Caon, R. Saad Hossne, F. Vieira Teixeira, Sabine Murakami Winkler, N. Sousa Freitas Queiroz
{"title":"Biosimilars in Inflammatory Bowel Diseases: General Concepts and Clinical Implications","authors":"Sabrina Rodrigues de Figueiredo, Ana Elisa Rabe Caon, R. Saad Hossne, F. Vieira Teixeira, Sabine Murakami Winkler, N. Sousa Freitas Queiroz","doi":"10.5772/intechopen.100452","DOIUrl":"https://doi.org/10.5772/intechopen.100452","url":null,"abstract":"The treatment of inflammatory bowel disease (IBD) has changed over time with the increasing use of biologics to achieve therapeutic goals. As a result, the cost of treatment increased considerably, making it necessary to develop strategies that could increase access to biological therapies. In this scenario, the biosimilars were developed with the aim of reducing costs, maintaining safety and efficacy compared to the originator. Initially, its use in IBD was based on the extrapolation of studies in other specialties, such as rheumatology. More recently, studies in inflammatory bowel disease have emerged, with favorable results for its use. It is known that there are still knowledge gaps in the use of biosimilars and more experience is needed to increase clinicians’ confidence in their clinical practice. This chapter proposes a review of what is currently known about biosimilars in IBD. It discusses about aspects such as safety, efficacy, interchangeability, immunogenicity and switches.","PeriodicalId":383787,"journal":{"name":"Biosimilars [Working Title]","volume":"53 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127883483","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}
Maria Chiara Ditto, S. Parisi, R. Talotta, M. Priora, R. Borrelli, E. Fusaro
{"title":"Rheumatic Diseases and Biosimilars: Evidence about Switch from Originators to Biosimilars in the Real Life","authors":"Maria Chiara Ditto, S. Parisi, R. Talotta, M. Priora, R. Borrelli, E. Fusaro","doi":"10.5772/intechopen.100128","DOIUrl":"https://doi.org/10.5772/intechopen.100128","url":null,"abstract":"Biosimilars are broadly available for the treatment of several diseases including inflammatory arthritis. Thanks to biosimilars it has been possible to treat a greater number of rheumatic patients who previously were undertreated due to the high cost of originators, in several countries. There are a lot of data from double blind, randomized, controlled clinical trials, especially on TNF inhibitors (TNFi), concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe mainly for economic reasons. However, despite the considerable saving, such shifts to biosimilar drugs are still being debated, principally over their ethical implications. Since the drugs are similar but not identical, the main issues are related to the possibility to compare the adverse events and/or the lack of efficacy and, to date, the variability in effectiveness for a single patient remains an unpredictable datum before effecting the switch. Despite encouraging data about the maintenance of efficacy and safety after the switch, there are many reports of discontinuation due both lack of efficacy or and adverse events. In this chapter we aim at showing the disease activity trend and the safety after the transition to TNF-i biosimilars in patients with rheumatic diseases in real life..","PeriodicalId":383787,"journal":{"name":"Biosimilars [Working Title]","volume":"160 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127085668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Monoclonal Antibodies for Cancer Treatment","authors":"A. Livinalli, T. Galvão","doi":"10.5772/INTECHOPEN.97915","DOIUrl":"https://doi.org/10.5772/INTECHOPEN.97915","url":null,"abstract":"Therapeutic monoclonal antibodies have emerged in the 1990 decade as an important option for cancer treatment. These molecules have a diverse set of clinically relevant antitumor mechanisms, directly targeting tumor cells. It has been established as “standard of care” for several human cancers. This chapter reviews the use of monoclonal antibodies in oncology and introduces available biosimilars. The requirements for biosimilar antibody development, mechanisms of action and current clinical applications for cancer treatment is also presented.","PeriodicalId":383787,"journal":{"name":"Biosimilars [Working Title]","volume":"150 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2021-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116733918","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}