Abstract

NOGUEIRA, Renato Maia et al. Biossimilars: Are They So Similar?. Medicina Interna [online]. 2020, vol.27, n.3, pp.69-71. ISSN 0872-671X.  https://doi.org/10.24950/PV/53/20/3/2020.

Biosimilars are complex proteins of high molecular weight, produced and purified from biologic products, in comparison to generic drugs, biosimilars are biologically similar to the reference drug while a generic is molecularly identical. We focus on the various biosimilar low weight heparins pretending to demonstrate which criteria were chosen to assure the efficacy and safety of these drugs when they were introduced in the market, comparing the recommendations written by various international societies in comparison with the European Medicine Agency guidelines and the criteria used the ensure these goals. It was verified that the evaluation of these drugs was based on laboratory assessment of its biological activity and underpowered studies of immunogenicity, being that the risks were extrapolated from the reference drug. For this reason, using these drugs carries an unacceptable human risk and a high economic risk since the cost of managing adverse complications can easily overwhelm its relative lower cost.

Keywords : Biosimilar Pharmaceuticals; Drugs, Generic; Heparin, Low-Molecular-Weight.

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