All publications of “Igor Age Kos”

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Partnership for productive development of biosimilar products: perspectives of access to biological products in the Brazilian market

Morton Aaron Scheinberg ORCID logo , Paulo Antonio Oldani Felix ORCID logo , Igor Age Kos ORCID logo , Maurício De Angelo Andrade ORCID logo , Valderilio Feijó Azevedo ORCID logo

DOI: 10.1590/S1679-45082018RW4175

ABSTRACT The manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the yearly budget for the Brazilian public health system. As the patents of biological products expire, several biosimilars are developed. However, there are concerns regarding their efficacy and safety; therefore, the regulatory agencies establish rules to approve and monitor these products. […]