Author byline as per print journal: Michael Wilcock, MPhil; Andrew Pothecary, MSc Introduction: Biological medicines are used to treat a range of conditions according to National Institute for Health and Care Excellence (NICE) technology appraisals. The annual drug treatment cost per patient per year varies depending on various factors, including newer or older biological, and […]
Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the […]
Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims […]
Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe and chronic diseases. The goal of the present study was to provide an overview of their current status in Iran. Methods: A comprehensive search of […]
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 earlier. Herein, current FDA regulations and hurdles encountered for US biosimilar approval and uptake are discussed. Submitted: 12 October 2020; Revised: 28 October 2020; Accepted: […]
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 to fund new medicines and increasing medicine volumes. Bertolani and Jommi document successful measures introduced regionally in Italy. The recent GaBI Journal manuscript by Bertolani […]
Author byline as per print journal: Arianna Bertolani, PhD; Claudio Jommi, MS Study Objectives: Different policies have been implemented to enhance uptake of biosimilars. Regarding policies focussing on the demand-side, the literature has mainly concentrated on interchangeability and substitutability recommendations, issued by national or regional policymakers. Information on actions taken by healthcare organisations (HCOs) regarding […]
Author byline as per print journal: Rieke Alten1, MD, PhD; Herbert Kellner2, MD; Malcolm Boyce3, MD; Takuma Yonemura4, MD; Takahiro Ito5, MSc; Mark C Genovese6, MD Introduction/Study objectives: FKB327 is a biosimilar of the adalimumab reference product. Studies in healthy subjects and patients with rheumatoid arthritis demonstrated biosimilarity between FKB327 and the reference product in […]
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 success as highly eff ective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support […]
Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia […]
Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodríguez-Burneo1, MD; Felipe Andrade2, MD; Damaris P Intriago-Baldeón4, MSc; Claudio Galarza-Maldonado5, MD, PhD Abstract: The number of approved biological medicines in the global pharmaceutical market has increased in […]
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 cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical […]
