Special Report

USA and Europe differ in interchangeability of biosimilars

Published in: Volume 6 / Year 2017 / Issue 4
Author(s):
Page: 183-4

Abstract: This paper highlights differences between USA and Europe when it comes to the interchangeability of biosimilars. The lack of harmonization between USA and Europe may introduce confusion for stakeholders and… Read More »

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing

Published in: Volume 6 / Year 2017 / Issue 4
Author(s):
Page: 181-2

Abstract: The European Commission held a stakeholder event to discuss biosimilar medicinal products in May 2017. A session on building stakeholder confidence in biosimilar medicines provided an update of the latest… Read More »

Physician associations comment on FDA’s interchangeability guidance

Published in: Volume 6 / Year 2017 / Issue 3
Author(s):
Page: 120-1

Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper. Various issues were discussed; this paper highlights… Read More »

Interchangeability of biosimilars in the US and around the world

Published in: Volume 6 / Year 2017 / Issue 2
Author(s):
Page: 97-8

Abstract: In this paper, differences across the world are highlighted when it comes to the interchangeability of biosimilars. The lack of harmonization makes it difficult for biosimilars makers and could… Read More »

Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US

Published in: Volume 6 / Year 2017 / Issue 2
Author(s): , , ,
Page: 89-96

Abstract: Kinase inhibitors form the largest class of novel anticancer drugs. To date, more than 20 kinase inhibitors have been approved for clinical use. Lengthy patent rights keep the cost… Read More »

Patent expiry dates for biologicals: 2016 update

Published in: Volume 6 / Year 2017 / Issue 1
Author(s):
Page: 27-30

Abstract: Biosimilars have been approved in Europe since 2006 and in the US since 2015. With patents on originator biologicals expiring and ever-tightening healthcare budgets, biosimilars are expected to take… Read More »

Generic medicines entry into the Malaysian pharmaceutical market

Published in: Volume 5 / Year 2016 / Issue 4
Author(s): , ,
Page: 180-1

Abstract: There are major barriers to generic medicine development and market entry in Malaysia. This mixed method study recommends strategies to increase uptake. Submitted: 25 October 2016; Revised: 15 November… Read More »

The role of European Pharmacopoeia monographs in setting quality standards for biotherapeutic products

Published in: Volume 5 / Year 2016 / Issue 4
Author(s):
Page: 174-9

Abstract: European Pharmacopoeia (Ph. Eur.) monographs for biotherapeutic products have existed since the 1990s and remain the publicly available standard defining the quality of these medicines. Continued development of such… Read More »

Competitive effects on the generics industry

Published in: Volume 5 / Year 2016 / Issue 3
Author(s):
Page: 144

Abstract: A study of the factors influencing generics makers’ decision on whether to enter a specific market found that firm size, market revenue and expected competition all had an effect.… Read More »

US FDA proposals for naming of biologicals and labelling of biosimilars

Published in: Volume 5 / Year 2016 / Issue 3
Author(s):
Page: 140-3

Abstract: There is considerable concern and debate over the naming of biologicals and labelling of biosimilars. To ensure that patients receive the safest and most effective treatment, it is paramount… Read More »

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