Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Published in: Volume 4 / Year 2015 / Issue 1
Author(s): , ,
Page: 36-41

Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing… Read More »

Regulation of biologicals in Malaysia

Published in: Volume 3 / Year 2014 / Issue 4
Author(s): ,
Page: 193-8

Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises… Read More »

Comparison of biosimilars guidelines

Published in: Volume 3 / Year 2014 / Issue 1
Page: 36-8

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… Read More »

Biosimilar development and regulation in Japan

Published in: Volume 2 / Year 2013 / Issue 4
Page: 207-8

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing… Read More »

US state legislation on biosimilars substitution

Published in: Volume 2 / Year 2013 / Issue 3
Page: 155-6

Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution.… Read More »

PMDA update: the current situation and future directions

Published in: Volume 2 / Year 2013 / Issue 1
Author(s): , ,
Page: 41-4

Abstract: The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the… Read More »

Tighter EU rules on pharmacovigilance for biologicals

Published in: Volume 1 / Year 2012 / Issue 2
Page: 56-7

Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as… Read More »

Regulatory pathway for approval of ‘biosimilars’ in Iran


Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by… Read More »

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