Relevant issues to biossimilars licensing

• Published in: Revista brasileira de epidemiologia Vol. 15; no. 4; p. 748
• Main Authors: Peres, Beatriz Serrapio, Padilha, Gabriela, Quental, Cristiane
• Format: Journal Article
• Language: English
• Published: Brazil 01.12.2012
• Subjects: Biological Products - pharmacokinetics; Biological Products - therapeutic use; Brazil; Drug Approval - legislation & jurisprudence; European Union; Humans; Licensure - legislation & jurisprudence; Therapeutic Equivalency; United States; United States; Brazil

When the patent of a drug expires, low cost generics may be introduced in market. Trial results that demonstrate the safety and efficacy of the reference product can be extrapolated to the generic, simplifying the approval process. This paradigm cannot be applied to biopharmaceutical products, large...