Biosimilars: an approach to current worldwide regulation frameworks.

Biosimilars: an approach to current worldwide regulation frameworks. Curr Clin Pharmacol. 2018 Oct 25;: Authors: Esteban E, Bustos RH, García JC, Jauregui E Abstract Developing new biological medicaments has led to the regulations and norms regarding such drugs, in terms of marketing, prescription, use, interchangeability and switching, have become fundamental aspects guaranteeing their safety, quality and effectiveness. Biologics are of great importance in treating patients suffering rheumatic, autoimmune, inflammatory, neoplastic and other diseases. The expiry/lapse of reference biologics or originators' patents has meant that developing biosimilars needs accompanying legal requirements for their approval in countries worldwide. This paper has thus been aimed at approaching the situation of biosimilar regulation worldwide, the pertinent technical concepts and difference in some countries of interest. PMID: 30360724 [PubMed - as supplied by publisher]
Source: Current Clinical Pharmacology - Category: Drugs & Pharmacology Authors: Tags: Curr Clin Pharmacol Source Type: research