title: [Biosimilars--opportunity or threat?].
abstract: Strong interest in biosimilars dates back several years. In the coming years the patent protection ends for subsequent biological drugs, including monoclonal antibodies. This paper organizes the most important facts related to the issue of biosimilars. A biosimilar is a biotherapeutic product which is similar in terms of quality, efficacy and safety to an already licensed reference biotherapeutic product'. It should be noted that biosimilars approved underthe current regulations of the European Medicines Agency (EMA) meet the stringent standards of safety, efficacy and immunogenicity. It is also important to realize that the biosimilar has the right to that name, if it is registered by regulatory authorities like EMA or FDA. One should not confuse biosimilar drugs with those which counterfeit or imitate. Clinical trials on the convertibility of innovative and biosimilar drugs are ongoing. Nevertheless,there is no regulatory framework and clear guidelines of conduct in this regard. In the near future, thanks to the registration of the first biosimilar monoclonal antibodies in rheumatology and gastroenterology the availability of biological treatment for patients should increase.
authors.affiliation: Klinika Reumatologii i Chorób Wewnetrznych, Uniwersytet Medyczny im. Piastów Slaskich we Wrocławiu. jurekswierkot0@poczta.onet.pl
authors.forename: Jerzy
authors.initials: J
authors.lastname: Swierkot
mesh_terms: D001688:Biological Products / Q000592:standards / Q000627:therapeutic use; D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use*; D002908:Chronic Disease / Q000188:drug therapy; D004335:Drug and Narcotic Control; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000592:standards*; D011044:Poland
chemical_list: D001688:Biological Products; D059451:Biosimilar Pharmaceuticals; D004364:Pharmaceutical Preparations