Special Report
Overview of the patent expiry of (non-)tyrosine kinase inhibitors approved for clinical use in the EU and the US
Author(s): Associate Professor Martine Lamfers, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Sieger Leenstra, MD, PhD, Subramanian Venkatesan, MSc
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
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
Author(s): Omotayo Fatokun, PhD, Professor Mohamed Azmi Hassali, PhD, Professor Mohamed Izham Mohamed Ibrahim, PhD
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
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
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
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
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
Author(s): Professor Gerrit Borchard, PharmD, PhD
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
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
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 »