Perspective

How to realize the potential of off-patent biologicals and biosimilars in Europe? Guidance to policymakers

Published in: Volume 7 / Year 2018 / Issue 2
Author(s): , , , , , , , , , ,
Page: 70-4

Introduction/Objectives: This manuscript aims to provide guidance to policymakers with a view to fostering a fair, competitive and sustainable market for off-patent biologicals and biosimilars in Europe. Methods: Individuals and… Read More »

40th anniversary of essential medicines: a loud call for improving its access

Published in: Volume 6 / Year 2017 / Issue 4
Author(s): , ,
Page: 174-7

Author byline as per print journal: Mohammad Bashaar, PhD; Professor Mohamed Azmi Hassali, PhD; Fahad Saleem, PhD Abstract: The soaring costs of medicine are a global dilemma. It was hoped that the… Read More »

Pharmacovigilance of biosimilars and other biologicals within the hospital: current practices and future challenges

Published in: Volume 6 / Year 2017 / Issue 1
Author(s): , ,
Page: 24-6

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire.… Read More »

Biosimilars in Italy: a gastroenterologist’s view

Published in: Volume 5 / Year 2016 / Issue 3
Author(s): , ,
Page: 131-3

Author byline as per print journal: Vito Annese, MD; Tommaso Gabbani, MD; Antonio Luca Annese, MD Abstract: The introduction of biological therapy has revolutionized the paradigm of treatment in the… Read More »

Are the perspectives regarding the use of biosimilars in the setting of haematology and blood and marrow transplant changing?

Published in: Volume 5 / Year 2016 / Issue 3
Author(s):
Page: 128-30

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of… Read More »

Regional management of biosimilars in Germany

Published in: Volume 5 / Year 2016 / Issue 3
Author(s):
Page: 125-7

Abstract: Biosimilars of tumour necrosis factor-alpha (TNF-α) inhibitors, such as infliximab or etanercept, have recently entered the market. The management of these new products by the healthcare systems differ between… Read More »

Pharmacovigilance on biologicals and biosimilars: a Danish perspective

Published in: Volume 5 / Year 2016 / Issue 3
Author(s):
Page: 123-4

Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several… Read More »

Importance of manufacturing consistency of the glycosylated monoclonal antibody adalimumab (Humira®) and potential impact on the clinical use of biosimilars

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): ,
Page: 70-3

Author byline as per print journal: Professor Paul J Declerck, PhD; Paul W Tebbey, PhD Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent… Read More »

New monoclonal antibody biosimilars approved in 2015 in Latin America: position statement of the Latin American Forum on Biosimilars on biosimilarity, interchangeability and extrapolation of indications

Published in: Volume 5 / Year 2016 / Issue 2
Author(s): , , , ,
Page: 66-9

Author byline as per print journal: Valderílio Feijó Azevedo1,2, Alejandra Babini3,4, Fabio Vieira Teixeira5,6, Igor Age Kos1,2, Pablo Matar7 Introduction: The Latin American Forum on Biosimilars (FLAB) is an annual… Read More »

Non-Biological Complex Drugs (NBCDs) and their follow-on versions: time for an editorial section

Published in: Volume 4 / Year 2015 / Issue 4
Author(s): , , , , , , , ,
Page: 167-70

Author byline as per print journal: Jon SB de Vlieger, PhD; Professor Stefan Mühlebach, PhD; Vinod P Shah, PhD; Scott E McNeil, PhD; Professor Gerrit Borchard, PharmD, PhD; Vera Weinstein, PhD; Beat Flühmann,… Read More »

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