Biosimilars
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…
