Nature reviews. Rheumatology
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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. ⋯ 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.
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Patient-reported outcomes (PROs) are abundant in rheumatology and their numbers continue to increase. But which of the available measures are most important? Core outcome sets-including groups of domains and instruments for measuring them-have been defined for many rheumatic diseases, with the aim that all these outcomes should be measured in every clinical trial. ⋯ Three PROs are commonly utilized across the majority of rheumatic conditions: pain, physical functioning and the patient global assessment of disease activity. However, additional research is needed to fully understand the role of the patient global assessment of disease activity, to distinguish specific domains within the broad concept of health-related quality of life, and to work towards consensus on the choice between generic and disease-specific instruments in various contexts.