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dc.contributor.authorScheinberg, Morton A.
dc.contributor.authorKay, Jonathan
dc.date2022-08-11T08:10:51.000
dc.date.accessioned2022-08-23T17:22:19Z
dc.date.available2022-08-23T17:22:19Z
dc.date.issued2012-06-05
dc.date.submitted2015-04-17
dc.identifier.citationNat Rev Rheumatol. 2012 Jun 5;8(7):430-6. doi: 10.1038/nrrheum.2012.84. <a href="http://dx.doi.org/10.1038/nrrheum.2012.84">Link to article on publisher's site</a>
dc.identifier.issn1759-4790 (Linking)
dc.identifier.doi10.1038/nrrheum.2012.84
dc.identifier.pmid22664834
dc.identifier.urihttp://hdl.handle.net/20.500.14038/48721
dc.description.abstractPatents for many key biological agents will soon expire. Third-party companies are, therefore, in the process of developing their own versions, termed biosimilar agents, of these innovator products. However, manufacture of biosimilar agents is complicated by the requirement for their production in biological systems, small variations in which can influence the structure, activity and metabolism of the biosimilar product. The development of biosimilar therapies for the treatment of patients with rheumatic diseases could potentially result in substantial cost savings for patients and health care providers, and consequently, increased availability of effective therapies. However, legislation that regulates the manufacture, registration and approval of biosimilar therapies varies considerably between different countries. In addition, major safety and efficacy concerns must be addressed before a rheumatologist can routinely substitute an innovator pharmaceutical with a biosimilar product.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=22664834&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1038/nrrheum.2012.84
dc.subjectAntirheumatic Agents
dc.subjectBiosimilar Pharmaceuticals
dc.subjectDrug Approval
dc.subjectDrug Substitution
dc.subjectHumans
dc.subjectRheumatic Diseases
dc.subjectRheumatology
dc.subject*Therapeutic Equivalency
dc.subjectComplex Mixtures
dc.subjectMusculoskeletal Diseases
dc.subjectRheumatology
dc.subjectSkin and Connective Tissue Diseases
dc.titleThe advent of biosimilar therapies in rheumatology--"O brave new world"
dc.typeJournal Article
dc.source.journaltitleNature reviews. Rheumatology
dc.source.volume8
dc.source.issue7
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/rheumatology_pubs/119
dc.identifier.contextkey7002947
html.description.abstract<p>Patents for many key biological agents will soon expire. Third-party companies are, therefore, in the process of developing their own versions, termed biosimilar agents, of these innovator products. However, manufacture of biosimilar agents is complicated by the requirement for their production in biological systems, small variations in which can influence the structure, activity and metabolism of the biosimilar product. The development of biosimilar therapies for the treatment of patients with rheumatic diseases could potentially result in substantial cost savings for patients and health care providers, and consequently, increased availability of effective therapies. However, legislation that regulates the manufacture, registration and approval of biosimilar therapies varies considerably between different countries. In addition, major safety and efficacy concerns must be addressed before a rheumatologist can routinely substitute an innovator pharmaceutical with a biosimilar product.</p>
dc.identifier.submissionpathrheumatology_pubs/119
dc.contributor.departmentDepartment of Medicine, Division of Rheumatology
dc.source.pages430-6


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