The regulatory landscape of biosimilars: WHO efforts and progress made from 2009 to 2019.

This article describes the progress made and the regulatory landscape changes for biosimilars in 21 countries during the past ten years. Based on the information from regulators and from publicly available data, the following has been identified: 1) WHO guidelines have contributed to setting the regulatory framework for biosimilars in countries and increasing regulatory convergence at global level; 2) terminology used for biosimilars is more consistent than in the past; 3) biosimilars are now approved in all participating countries; and 4) the dominant product class for candidate biosimilars under development is monoclonal antibodies.
PMID: 32224101 [PubMed - as supplied by publisher]

Source: Biologicals : Journal of the International Association of Biological Standardization - March 26, 2020 Category: Biotechnology Authors: Kang HN, Thorpe R, Knezevic I, Survey participants from 19 countries Tags: Biologicals Source Type: research