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    Biosimilars in rheumatology: current perspectives and lessons learnt

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    Authors
    Dorner, Thomas
    Kay, Jonathan
    UMass Chan Affiliations
    Department of Medicine, Division of Rheumatology
    Document Type
    Journal Article
    Publication Date
    2015-12-01
    Keywords
    Rheumatology
    Therapeutics
    
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    Link to Full Text
    http://dx.doi.org/10.1038/nrrheum.2015.110
    Abstract
    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.
    Source
    Nat Rev Rheumatol. 2015 Dec;11(12):713-24. doi: 10.1038/nrrheum.2015.110. Epub 2015 Aug 18. Link to article on publisher's site
    DOI
    10.1038/nrrheum.2015.110
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/30568
    PubMed ID
    26282080
    Related Resources
    Link to Article in PubMed
    ae974a485f413a2113503eed53cd6c53
    10.1038/nrrheum.2015.110
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