publication . Article . 2014

The portuguese society of rheumatology position paper on the use of biosimilars

Fonseca, J. E.; Gonçalves, J.; Araújo, F.; Cordeiro, I.; Teixeira, F.; Canhão, H.; José António Pereira da Silva; Garcês, S.; Miranda, L. C.; Ramiro, S.; ...
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Open Access
  • Published: 01 Jan 2014
  • Country: Portugal
Abstract
Biotechnological drugs have become a fundamental resource for the treatment of rheumatic patients. Patent expiry of some of these drugs created the opportunity for biopharmaceutical manufacturers to develop biosimilar drugs intended to be as efficacious as the originator product but with a lower cost to healthcare systems. Due to the complex manufacturing process and highly intricate structure of biologicals, a biosimilar can never be an exact copy of its reference product. Consequently, regulatory authorities issued strict preclinical and clinical guidelines to ensure safety and efficacy equivalence and, in September 2013, the biosimilar of infliximab was the f...
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handle: 10400.4/2100
Subjects
free text keywords: Doenças Reumáticas, Medicamentos Biossimilares
Related Organizations
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