The current status of biosimilar biologics – Part 1: An international perspective.

Europe set a precedent in 2006 by approving the first biosimilar medicines for human use. This led to the establishment of supporting laws and regulations in other major regions such as Canada in 2009, South Africa in 2009, Australia in 2009, Malaysia in 2009, the US in 2010 and a WHO international guidance in 2010. This article is the first in a two-part discussion of the evolution of global biosimilars guidance and regulations. Part 2, to be published in an upcoming issue of Regulatory Rapporteur, will look at the global development landscape for biosimilars. Read More