Etanercept was the first tumour necrosis factor\nalpha antagonist approved in the USA for the treatment of\nrheumatoid arthritis, in 1998, and then for other diseases.\nWith the etanercept patent set to expire in the EU in 2015,\na number of etanercept copies have reached the production\nphase and are undergoing clinical trials, with the promise\nof being cheaper alternatives to the reference product. In a\nglobal scenario that is favourable to the entry of biosimilars,\nthis article discusses the stage of development, manufacture,\nclinical trials and the regulatory process involved\nin the approval of etanercept biosimilars, compiling the\nliterature data. Reducing treatment cost is the principal\nattraction for biosimilars to emerge in the global market.\nIt is essential for the doctors� decision on the prescription\nof these medications, as well as for payers, to have clearly\ndefined studies of clinical equivalence, quality, and safety\nin order to better evaluate the various copies of etanercept.\nThe authors discuss the need to harmonize different\nnational regulations and the introduction of effective\npharmacosurveillance systems for prompt recognition of\nadverse effects in copies of biopharmaceuticals that differ\nfrom those found in the reference products.
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