Special Report

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 »

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 »

Improving biosimilars uptake: experience gained in Madrid, Spain

Published in: Volume 5 / Year 2016 / Issue 2
Author(s):
Page: 89-91

Abstract: How to improve the uptake of biosimilars is a question that many countries are finding a challenge. Researchers from the Madrid Health Service investigate how initiatives in Spain have… Read More »

Complexity in the making: non-biological complex drugs (NBCDs) and the pharmacopoeias

Published in: Volume 5 / Year 2016 / Issue 1
Author(s):
Page: 36-41

Abstract: Pharmacopoeias, as standard references for pharmaceutical drug specifi cations and reference standards in the form of monographs, play a pivotal role to assure drug quality and safety. With emphasis… Read More »

Patent expiry dates for best-selling biologicals

Published in: Volume 4 / Year 2015 / Issue 4
Author(s):
Page: 178-9

Abstract: Biosimilars have been approved in Europe since 2006. With patents on originator biologicals expiring and ever-tightening healthcare budgets biosimilars are likely to take an increasing share of the biologicals… Read More »

Supporting biosimilarity and extrapolation

Published in: Volume 4 / Year 2015 / Issue 4
Author(s):
Page: 180-3

Abstract: With many biosimilars being approved around the world, there is an urgent need for clear guidelines on establishing biosimilarity and on approving subsequent extrapolation. The balance between clinical studies… Read More »

Analysis of European policy towards generic medicines

Published in: Volume 3 / Year 2014 / Issue 1
Author(s): , ,
Page: 34-5

Abstract: In this paper, we provide an overview of a PhD project we undertook on European policy on generic medicines. In the course of our research, we identified various causes… Read More »

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