Biossimilars: Are They So Similar?
DOI:
https://doi.org/10.24950/PV/53/20/3/2020Keywords:
Biosimilar Pharmaceuticals, Drugs, Generic, Heparin, Low-Molecular-WeightAbstract
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.
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Curtis JR, Schabert VF, Harrison DJ, Yeaw J, Korn, JR, Quach C, Yun H, Joseph GJ, Collier DH. Estimating effectiveness and cost of biologics for rheumatoid arthritis: application of a validated algorithm to commercial insurance claims. Clin Ther.2014;36:996-1004.
Harenberg J, Walenga J, Torri G, Dahl OE, Drouet L, Fareed J; Subcommittee on Control of Anticoagulation, Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Update of the recommendations on biosimilar low molecularweight heparins from the Scientific Subcommittee on Control of Anticoagulation of the International Society on Thrombosis and Haemostasis. J Thromb Haemost. 2013; 11: 1421–5
Kalodiki E, Leong W; SASAT and Task Force on Generic LMWHs. SASAT (South Asian Society on Atherosclerosis & Thrombosis) proposal for regulatory guidelines for generic low-molecular weight heparins (LMWHs). . Clin Appl Thromb Hemost. 2009;15:8-11. doi: 10.1177/1076029608329113.
Guideline on similar biological medicinal products. European Medical Agency. CHMP/437/04 Rev 1. [consultado Jan 2020] disponível em: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Acessado a 10 Jan 2020.
Assessment report. Thorinane. International non-proprietary name: enoxaparin sodium. Procedure No. EMEA/H/C/003795/0000.
EMA/536972/2016. Committee for Medicinal Products for Human Use (CHMP). [consultado Jan 2020] disponível em http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003795/WC500215281.pdf. Acesso em: 22 jan. 2020.
Assessment report. Inhixa. International non-proprietary name: enoxaparin sodium. Procedure No. EMEA/H/C/004264/0000. EMA/536977/2016. Committee for Medicinal Products for Human Use (CHMP). [consultadoJan 2020] disponível em http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004264/WC500215211.pdf. Acesso em: 22 jan. 2020.
European Medicines Agency, Committee for Medicinal Products for Human Use. Guideline on non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins. 2009. [consultado Jan 2020] disponível em http://www.ema.europa.eu/docs/en _GB/document_library/Scientific _guideline/2009/09/WC500003927.pdf Acessado em 10 Jan 2020
Sampaio RF, Mancini MC. Estudos de revisão sistemática: um guia para síntese criteriosa da evidência científica. Rev Bras Fisio. 2007;11:83-9.
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