Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?

Published in: Volume 12 / Year 2023 / Issue 2
Page: 61-6

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic… Read More »

Can local policies on biosimilars optimize the use of freed resources – experiences from Italy

Published in: Volume 9 / Year 2020 / Issue 4
Author(s): , , ,
Page: 183-7

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, MSc, PhD; Hye-Young Kwon, PhD1,6 Abstract: There is an increasing need to prescribe biosimilars… Read More »

An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa

Published in: Volume 9 / Year 2020 / Issue 1
Page: 22-4

Abstract: Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of… Read More »

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

Author byline as per print journal: Steven Simoens, PhD; Claude Le Pen, PhD; Niels Boone, PharmD; Ferdinand Breedveld, MD, PhD; Antonella Celano; Antonio Llombart-Cussac, MD, PhD; Frank Jorgensen, MPharm, MM;… 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
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
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
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 »

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