Jornal Vascular Brasileiro
https://jvascbras.org/article/doi/10.1590/S1677-54492010000300008
Jornal Vascular Brasileiro
Review Article

Estudos de medicamentos biosimilares

Studies on biosimilar medications

Winston Bonetti Yoshida

http://dx.doi.org/10.1590/S1677-54492010000300008 J Vasc Bras, vol.9, n3, p.141-144, 2010
PDF Português
PDF English
Downloads: 0
Views: 1208

Resumo

No Brasil, o registro de novos medicamentos é feito apenas quando a agência reguladora - Agência Nacional de Vigilância Sanitária (Anvisa) - se satisfaz plenamente com as evidências de sua qualidade, eficácia e segurança, apresentadas por uma indústria farmacêutica que pleiteie esse registro. Com o vencimento de patentes, empresas farmacêuticas se sentem atraídas pela produção medicamentos biológicos chamados de biosimilares ou biogenéricos ou simplesmente genéricos, cuja aprovação pode resultar em redução de custos de tratamento. Mas é preciso que o biosimilar seja, pelo menos, igualmente eficaz e seguro e sem contaminantes em relação ao original. Consensos recentes apontam diretrizes para estabelecer critérios de eficácia e segurança desses medicamentos. Estudos pré-clínicos in vitro e in vivo, procedência da matéria-prima e estudos clínicos fase I, II e III são preconizados para registro do produto biosimilar no mercado internacional. As heparinas de baixo peso molecular encontram-se nessa situação. Nesta revisão, abordamos especificamente esse tipo de medicamento, o que pode servir de parâmetro para outros biosimilares.

Palavras-chave

Heparina, heparina de baixo peso molecular, medicamentos genéricos, guias de prática clínica como assunto, equivalência terapêutica

Abstract

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Anvisa, acronym in Portuguese) is fully satisfied with the evidence of their quality, efficacy and safety, presented by a pharmaceutical industry that strive for this registration. With the patent expiration, pharmaceutical companies are attracted to produce biological medicines called biosimilar or biogenerics or simply generics, whose approval may result in reduced treatment costs. But it is necessary that the biosimilar be, at least, equally effective and safe and without contaminants in relation to the original. Recent consensus guidelines aim to establish criteria for efficacy and safety of these medicines. Preclinical studies in vitro and in vivo, the origin of raw materials and clinical studies phase I, II and III are recommended for biosimilar medicine registration in the international market. Low molecular weight heparins are found in this situation. In this review we specifically addressed this type of medicine, which could serve as a benchmark for other biosimilar medicines.

Keywords

Heparin, heparin, low-molecular-weight, drugs, generic, practice guidelines as topic, therapeutic equivalence

References

Medicamentos. .

Harenberg J, Kakkar A, Bergqvist D. Recommendations on biosimilar low-molecular-weight heparins. J Thromb Haemost. 2009;7:1222-5.

Kishimoto TK, Viswanathan K, Ganguly T. Contaminated heparin associated with adverse clinical events and activation of the contact system. N Engl J Med. 2008;358:2457-67.

Nosé Y. Hemodialysis patients' deaths in the USA by contaminant suspected heparin originating from China. Artif Organs. 2008;32:425-6.

Cavalheiro Filho C, Chamone Dde A, Rached RA, Maffei FH. Heparins - current status. Rev Assoc Med Bras. 2008;54:471-2.

Melo EI, Pereira MS, Cunha RS, Sá MP, Mourão PA. Heparin quality control in the Brazilian market: implications in the cardiovascular surgery. Rev Bras Cir Cardiovasc. 2008;23:169-74.

Guerrini M, Guglieri S, Naggi A, Sasisekharan R, Torri G. Low molecular weight heparins: structural differentiation by bidimensional nuclear magnetic resonance spectroscopy. Semin Thromb Hemost. 2007;33:478-87.

Gray E, Mulloy B, Barrowcliffe TW. Heparin and low-molecular-weight heparin. Thromb Haemost. 2008;99:807-18.

Gray E, Rigsby P, Behr-Gross ME. Collaborative study to establish the Low-molecular-mass heparin for assay-: European Pharmacopoeia Biological Reference Preparation. Pharmeuropa Bio. 2004;2004:59-76.

Fareed J, Bick R. Differentiation of low-molecular-weight heparins: practical implications. Clin Appl Thromb Hemost. 2004;10:299-300.

Maffei FH, Pinto AM, Fabris VE, Lastória S, Rollo HD. Experimental venous thrombosis in guinea pigs: effect of heparin and drugs affecting platelet function (author's transl). Rev Bras Pesqui Med Biol. 1977;10:369-78.

Maffei FH, Rollo HA, Fabris VE. Prevention of experimental venous thrombosis induced by contrast medium in the rat. Acta Radiol Diagn (Stockh). 1980;21:249-52.

Lastória S, Thomazini IA, Cury PR, Maffei FH. Platelet activation in experimental arterial thrombosis. Braz J Med Biol Res. 1987;20:611-3.

Yoshida WB, Maffei FH, Lastória S, Curi PR, Rollo HA. Lumbar sympathectomy and distal arteriovenous fistula as adjuncts to prevent arterial rethrombosis after thrombectomy: experimental study in dogs. J Cardiovasc Surg (Torino. 1988;29:19-25.

Lim W, Dentali F, Eikelboom JW, Crowther MA. Meta-analysis: low-molecular-weight heparin and bleeding in patients with severe renal insufficiency. Ann Intern Med. 2006;144:673-84.

Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295:1152-60.

Rothmann MD, Tsou HH. On non-inferiority analysis based on delta-method confidence intervals. J Biopharm Stat. 2003;13:565-83.

Comparação de duas proporções. .

D'Agostino RB Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med. 2003;22:169-86.

Halvorsen PA, Selmer R, Kristiansen IS. Different ways to describe the benefits of risk-reducing treatments: a randomized trial. Ann Intern Med. 2007;146:848-56.

McQuay HJ, Moore RA. Using numerical results from systematic reviews in clinical practice. Ann Intern Med. 1997;126:712-20.

Jüni P, Witschi A, Bloch R, Egger M. The hazards of scoring the quality of clinical trials for meta-analysis. JAMA. 1999;282:1054-60.

Pinto V. Seminário sobre Estudos de Não-Inferioridade: III Fórum de atualização em medicamentos biológicos; 2010 Fev 26. 2010.

Sociedade Brasileira de Angiologia e Cirurgia Vascular (SBACV)"> Sociedade Brasileira de Angiologia e Cirurgia Vascular (SBACV)">
5dded2eb0e882527527279a2 jvb Articles
Links & Downloads
1677-7301 (Electronic)
J Vasc Bras ©2024 All rights reserved.

J Vasc Bras

Share this page
Page Sections