What is it about?
The biosimilars are non-identical copies of original biological products, which are complex, expensive and rapidly expanding drugs. Biosimilars offer the advantage of cost reduction, but require some legal care regarding their approval for different indications, and for exchange with the original product. We made a critical view of the strengths and weaknesses of the Brazilian regulation on biosimilars, comparing to regulations in Europe and USA.
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Why is it important?
It is very important that we have technical terms and denominations of universal understanding, as well as regulatory parameters of biosimilars prescription, so that their possible advantages can be evaluated with comparable efficiency without losing safety.
Perspectives
We can sensitize professionals dealing with biosimilars and people involved with its regulation so that legislation and the use of biosimilars can be improved.
PhD Marcos Renato de Assis
Faculdade de Medicina de Marília (Famema)
Read the Original
This page is a summary of: Strengths and weaknesses of the Brazilian regulation on biosimilars: A critical view of the regulatory requirements for biosimilars in Brazil, Therapeutic Advances in Musculoskeletal Disease, October 2018, SAGE Publications,
DOI: 10.1177/1759720x18809683.
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