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dc.contributor.authorDorner, Thomas
dc.contributor.authorKay, Jonathan
dc.date2022-08-11T08:08:33.000
dc.date.accessioned2022-08-23T15:59:01Z
dc.date.available2022-08-23T15:59:01Z
dc.date.issued2015-12-01
dc.date.submitted2016-01-07
dc.identifier.citationNat Rev Rheumatol. 2015 Dec;11(12):713-24. doi: 10.1038/nrrheum.2015.110. Epub 2015 Aug 18. <a href="http://dx.doi.org/10.1038/nrrheum.2015.110">Link to article on publisher's site</a>
dc.identifier.issn1759-4790 (Linking)
dc.identifier.doi10.1038/nrrheum.2015.110
dc.identifier.pmid26282080
dc.identifier.urihttp://hdl.handle.net/20.500.14038/30568
dc.description.abstractBiosimilars, based on biopharmaceuticals approved by regulatory agencies that are no longer under patent protection, have efficacy and safety comparable to their reference products, and are a new therapeutic option to treat inflammatory diseases. Biosimilars must be distinguished from 'biomimics' or 'biocopies', which are marketed in some countries but have not been evaluated according to the stringent regulatory pathway used for biosimilars. CT-P13, based on infliximab, was the first biosimilar approved for the treatment of inflammatory diseases; however, some countries did not allow extrapolation of indications to all eight diseases for which the reference drug infliximab is approved. Antidrug antibodies can reduce drug levels and affect clinical efficacy, but although available data suggest that biosimilars and their reference products have comparable immunogenicity, this important property might differ between individual biopharmaceuticals. This Review discusses biosimilars already approved within the past 3 years to treat rheumatic diseases, as well as others that are currently under development. The main challenges posed by biosimilars are also addressed, such as the extrapolation of indications to diseases only studied for the reference drug, and the definition of strategies for adequate pharmacovigilance to monitor biosimilars after marketing approval.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=26282080&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1038/nrrheum.2015.110
dc.subjectRheumatology
dc.subjectTherapeutics
dc.titleBiosimilars in rheumatology: current perspectives and lessons learnt
dc.typeJournal Article
dc.source.journaltitleNature reviews. Rheumatology
dc.source.volume11
dc.source.issue12
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/faculty_pubs/846
dc.identifier.contextkey7992986
html.description.abstract<p>Biosimilars, based on biopharmaceuticals approved by regulatory agencies that are no longer under patent protection, have efficacy and safety comparable to their reference products, and are a new therapeutic option to treat inflammatory diseases. Biosimilars must be distinguished from 'biomimics' or 'biocopies', which are marketed in some countries but have not been evaluated according to the stringent regulatory pathway used for biosimilars. CT-P13, based on infliximab, was the first biosimilar approved for the treatment of inflammatory diseases; however, some countries did not allow extrapolation of indications to all eight diseases for which the reference drug infliximab is approved. Antidrug antibodies can reduce drug levels and affect clinical efficacy, but although available data suggest that biosimilars and their reference products have comparable immunogenicity, this important property might differ between individual biopharmaceuticals. This Review discusses biosimilars already approved within the past 3 years to treat rheumatic diseases, as well as others that are currently under development. The main challenges posed by biosimilars are also addressed, such as the extrapolation of indications to diseases only studied for the reference drug, and the definition of strategies for adequate pharmacovigilance to monitor biosimilars after marketing approval.</p>
dc.identifier.submissionpathfaculty_pubs/846
dc.contributor.departmentDepartment of Medicine, Division of Rheumatology
dc.source.pages713-24


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