Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars. Submitted: 18 December 2014; Revised: 23 February 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 The legislative basis for the regulation of […]
Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that […]
Abstract: 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 […]
Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication. The confusion is […]
