Biosimilars
Conference report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
Abstract The 6th Global CRO Council for Bioanalysis (GCC) Closed Forum was held on 27 March 2012 in San Antonio, TX, USA, the day before…
Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
Abstract Imminent patent expiry for a number of biological products currently on the market (many of which are blockbusters) has created an increasing opportunity for…
Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development
Abstract With the imminent expiry of patents on a number of biological products on the market, the development of biosimilars (or ‘follow-on biologics’) creates an…
