Commentary
A white paper: US biosimilars market on pace with Europe
Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq
Page: 150-4
Abstract: In the US, 28 biosimilars have been approved, with 10 in the last two years. The US is keeping pace with the EU who pioneered biosimilars approvals a decade… Read More »
Quality standards for biopharmaceuticals: the importance of good manufacturing practice
Abstract: Regulatory standards for recombinant DNA (rDNA)-derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their… Read More »
Importance of the determination of the higher order structure in the in-use stability studies of biopharmaceuticals
Author(s): Professor Alain Astier, PharmD, PhD
Page: 49-51
Abstract: Knowledge of the higher order structure of proteins is important in biopharmacological studies, such as in biosimilar comparability studies. This paper describes the analytical methods available to determine higher… Read More »
Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective
Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc
Page: 93-7
Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement… Read More »
Medicines regulation in the MENA region and the importance of the World Health Organization’s INN proposal of Biological Qualifier
Author(s): 3 Peter J Pitts, BA, Michael S Reilly, Esq
Page: 97-100
Author byline as per print journal: Peter J Pitts, BA; Michael S Reilly, Esq Abstract: The World Health Organization should finalize its Biological Qualifier guidance. Distinguishable naming will allow quick and… Read More »
Potential changes to the FDA approach to biosimilars have a global impact
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Page: 53-5
Abstract: The Opinion article of Niazi urges the US Food and Drug Administration (FDA) to make adjustments to its guidance on biosimilar development. This article comments on some of the… Read More »
EU Member States have tools to reduce costs of bestseller biologicals but can they use them?
Author(s): Adjunct Professor Pekka Kurki, MD, PhD
Page: 5-7
Abstract: Major cost savings are achievable in pharmacotherapy in the European Union since biosimilars to most best-selling biological medicinal products have been licensed. Unfortunately, the window of opportunity may be… Read More »
Global policies on pharmacy-mediated substitution of biosimilars: a summary
Author(s): Thijs J Giezen, PharmD, PhD, MSc
Page: 155-6
Abstract: An extensive overview of policies related to pharmacy-mediated substitution of biosimilars across the world was carried out by Larkin et al. in 2017. The details of this are discussed… Read More »
Patent expiry and costs for anticancer medicines for clinical use
Author(s): Alan Haycox, PhD, Brian Godman, BSc, PhD, Claudia Wild, PhD
Page: 105-6
Author byline as per print journal: Brian Godman, BSc, PhD; Claudia Wild, PhD; Alan Haycox, PhD Abstract: Venkatesan S et al. have researched patent rights and pricing for (non-)tyrosine kinase inhibitors.… Read More »
Substitution and interchangeability: time for a conversation?
Page: 49-50
Author byline as per print journal: Chad Rieger1, MBA; Lisa Hall1, PhD; David Lim2,3, DPH Abstract: Bandiera et al. (2002) identified the potential for competitors’ promotional materials to use certain… Read More »