Capturing the holistic value of biosimilars in Europe–part 1: a historical perspective

J Mestre-Ferrandiz, M Czech, JS Smolen… - Expert Review of …, 2024 - Taylor & Francis
Introduction Approved biosimilars exhibit comparable efficacy, safety, and immunogenicity to
reference products. This report provides perspectives on the societal value of biosimilars …

The use of biosimilar medicines in oncology-position statement of the Brazilian Society of Clinical Oncology (SBOC)

GS Fernandes, C Sternberg, G Lopes… - Brazilian journal of …, 2018 - SciELO Brasil
A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the
manufacturing process of which hinders the ability to identically replicate the structure of the …

[PDF][PDF] A patient centered paradigm for the biosimilars market

J Class, L Langis - GaBI Journal, 2012 - gabi-journal.net
In the history of medicine, biologicals are relatively new products. Biologicals developed in
the 1980s produced an impact in nephrology, oncology, and other therapeutic areas. The …

From bioequivalence to biosimilarity: the rise of a novel regulatory framework

VD Karalis - Drug research, 2016 - thieme-connect.com
One of the most crucial issues in pharmacotherapy is to address the query if a patient can be
switched from one product to another of the same active substance. For the conventional …

Biosimilars: A futuristic fast-to-market advice to developers

SK Niazi - Expert Opinion on Biological Therapy, 2022 - Taylor & Francis
Introduction Biosimilars are expected to improve the accessibility of biological drugs, a goal
that has not been reached because of the high cost of development. This is about to change …

[HTML][HTML] Preparing for the incoming wave of biosimilars in oncology

E Wolff-Holz, JG Burgos, R Giuliani, G Befrits… - ESMO open, 2018 - Elsevier
With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders
including a clinician, specialist nurse, patient advocate, regulator and economist provide …

[PDF][PDF] Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective

B Godman, E Allocati… - Generics and Biosimilars …, 2019 - pureportal.strath.ac.uk
Commentary Article Ever-Evolving landscape of biosimilars in Canada; findings and implications
from a global perspective Brian G Page 1 1 Commentary Article Ever-Evolving landscape of …

Biosimilars: a cure to the US health care cost conundrum?

BR Hirsch, GH Lyman - Blood Reviews, 2014 - Elsevier
As the cost of healthcare continues to rise and patents on biologics near expiration,
biosimilars are gaining visibility as a mechanism for cost reduction. Yet, the introduction of …

WHO guidelines on biosimilars: toward improved access to safe and effective products

HN Kang, M Wadhwa, I Knezevic… - Annals of the New …, 2023 - Wiley Online Library
Abstract The World Health Assembly resolution on access to biotherapeutics in 2014 urges
WHO and Member States to facilitate access to biotherapeutics while ensuring their quality …

Biosimilars: are they ready for primetime in the United States?

BR Hirsch, GH Lyman - Journal of the National Comprehensive Cancer …, 2011 - jnccn.org
The introduction of alternative versions of biologic products, also known as biosimilars, into
the United States market has been gaining increasing visibility as patents for many agents …