Guidelines on evaluation of biosimilars

Overview

These WHO Guidelines are intended to provide globally acceptable principles for the licensing of biological products that are claimed to be similar to biological products of assured quality, safety and efficacy that have been licensed based on a full licensing dossier. On the basis of proven similarity, the licensing of a biosimilar would in part rely on nonclinical and clinical data generated for an already licensed originator product. These Guidelines can be adopted by NRAs worldwide or used as a basis for establishing national regulatory frameworks for the licensure of such biosimilars. The Guidelines apply to biological products that can be well characterized, such as recombinant DNA-derived therapeutic peptides and proteins. Some of the principles provided in these Guidelines may also apply to low molecular weight heparins and recombinant analogues of plasma-derived products. Vaccines and plasma-derived products are excluded from the scope of these Guidelines.