Biosimilars: what the dermatologist should know.

摘要: Biosimilars are highly similar versions of approved branded biologics. In contrast to generics, which identical copies the originator medicines, biosimilars considered unique but related molecules that differ from reference product as well each other. Owing complexity biologic such therapeutic monoclonal antibodies, minor differences between and products acceptable provided these do not result in any clinically meaningful safety or efficacy. addition, changes structure function may occur over time a alterations production materials (e.g. cell lines), processes conditions. The developmental process for focuses on 'totality evidence' approach emphasizes stepwise investigational process, including comprehensive structural, functional, pharmacologic clinical assessment similarity. goal phase 3 development programme biosimilar is establish efficacy, per se, demonstrate there no proposed product. requirement show similarity informs study design, selection patient population, disease state (indication), endpoints statistical methods. Based trial results representative be extrapolated other indications scientific justification demonstrated based on, among things, mechanism action indications. This review presents current knowledge with respect biosimilars. We aim provide practising clinician working some practical guidance their use potential benefits treating dermatologic diseases.