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The production of biopharmaceuticals in Brazil: current issues BJPS
Pimenta,Marcela Valente; Monteiro,Gisele.
Biopharmaceuticals are gaining a growing share of the pharmaceuticals market. In recent years, the Brazilian Health Surveillance Agency (ANVISA) has approved the registration of biological drugs with domestic production. Although Brazil is in the early stages of biopharmaceutical production, governmental incentives and the investment in private companies in the technological domain in this country have created expectations of an increase in the capacity of biopharmaceutical production. Private initiatives, once rare, have now started to blossom in this field, such as collagenase from Cristalia and filgrastim from Eurofarm. The expiry of the patents for certain biopharmaceuticals (e.g. infliximab, filgrastim and rituximab) has generated the possibility of...
Tipo: Info:eu-repo/semantics/article Palavras-chave: Biopharmaceutical; Biosimilar; Biological drugs; Brazilian biopharmaceutical market.
Ano: 2019 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502019000100599
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The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC) BJMBR
Fernandes,G.S.; Sternberg,C.; Lopes,G.; Chammas,R.; Gifoni,M.A.C.; Gil,R.A.; Araujo,D.V..
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of...
Tipo: Info:eu-repo/semantics/other Palavras-chave: Immunobiologicals; Therapeutic antibodies; Biosimilar; Cancer management; Access.
Ano: 2018 URL: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0100-879X2018000300401
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