Biosimilars in rheumatology: current perspectives and lessons learnt

摘要: Biosimilars, based on biopharmaceuticals approved by regulatory agencies that are no longer under patent protection, have efficacy and safety comparable to their reference products, a new therapeutic option treat inflammatory diseases. Biosimilars must be distinguished from 'biomimics' or 'biocopies', which marketed in some countries but not been evaluated according the stringent pathway used for biosimilars. CT-P13, infliximab, was first biosimilar treatment of diseases; however, did allow extrapolation indications all eight diseases drug infliximab is approved. Antidrug antibodies can reduce levels affect clinical efficacy, although available data suggest biosimilars products immunogenicity, this important property might differ between individual biopharmaceuticals. This Review discusses already within past 3 years rheumatic diseases, as well others currently development. The main challenges posed also addressed, such only studied drug, definition strategies adequate pharmacovigilance monitor after marketing approval.