Special Report

Patent expiry dates for biologicals: 2017 update

Published in: Volume 7 / Year 2018 / Issue 1
Author(s):
Page: 29-34

Abstract: Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing… Read More »

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… 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… 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Abstract: Comments from physician associations on the US Food and Drug Administration’s draft guidance on interchangeability of biosimilars are presented in this paper.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

Author byline as per print journal: Subramanian Venkatesan, MSc; Associate Professor Martine Lamfers, PhD; Professor Sieger Leenstra, MD, PhD; Professor Arnold G Vulto, PharmD, PhD, FCP Abstract: Kinase inhibitors form the… 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

Author byline as per print journal: Omotayo Fatokun, PhD; Professor Mohamed Izham Mohamed Ibrahim, PhD; Professor Mohamed Azmi Hassali, PhD Abstract: There are major barriers to generic medicine development and market… 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 »

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