Nota: A tradução desta entrada está atualmente em revisão de qualidade, portanto parte do conteúdo é exibida temporariamente apenas em inglês.
Este verbete ainda não foi traduzido para o seu idioma, portanto o original é exibido abaixo.
biosimilar
This term is a specialized technical descriptor used primarily in pharmacology, regulatory law, and healthcare economics. It describes a specific relationship between a biological drug and its reference product, emphasizing that while the two are not identical copies—due to the inherent complexity of living cells—they are functionally equivalent in clinical outcomes.
In a professional medical or legal context, "biosimilar" is preferred over "generic" because biological products are too complex to be synthesized exactly. Using "generic" to describe a biosimilar is technically inaccurate and may be flagged in regulatory documentation or scientific peer reviews.
Meanings
A biological medicinal product that is highly similar to another biological medicinal product already approved for use, and which has no clinically meaningful differences in terms of safety, purity, and potency.
The regulatory agency approved a new biosimilar for the treatment of rheumatoid arthritis.