Perspective
Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health
Page: 55-60
Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimilar programme has been highly successful with 53 biosimilars approved… Read More »
Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements
Page: 27-33
Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA Introduction: Healthcare providers often lack familiarity… Read More »
Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Page: 23-6
Abstract: In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the current stringent and non-harmonized regulatory practices hinder competition and contribute to the high… Read More »
Ethnic sensitivity assessments in biosimilar monoclonal antibodies clinical development programmes: necessary or not?
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
Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc, Hye-Young Kwon, BPharm, MPH, PhD
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
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 »
Biosimilars in Italy: a gastroenterologist’s view
Author(s): Antonio Luca Annese, MD, Tommaso Gabbani, MD, Vito Annese, MD
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 »