GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 3 / Year 2014 / Issue 1
Regulatory
Comparison of biosimilars guidelines
Author(s): GaBI Journal Editor
Page: 36-8Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this […]