Regulatory and clinical considerations for biosimilar oncology drugs

CL Bennett, B Chen, T Hermanson, MD Wyatt… - The Lancet …, 2014 - thelancet.com
Biological oncology products are integral to cancer treatment, but their high costs pose
challenges to patients, families, providers, and insurers. The introduction of biosimilar …

Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology

E Mysler, C Pineda, T Horiuchi, E Singh… - Rheumatology …, 2016 - Springer
Biologics are vital to the management of patients with rheumatic and musculoskeletal
diseases such as rheumatoid arthritis and other inflammatory and autoimmune conditions …

Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice

AD Cohen, JJ Wu, L Puig, S Chimenti… - British Journal of …, 2017 - academic.oup.com
The introduction of biological drugs for the treatment of patients with psoriasis has
revolutionized treatment paradigms and enabled numerous patients to achieve disease …

Etanercept biosimilars

VF Azevedo, N Galli, A Kleinfelder, J D'Ippolito… - Rheumatology …, 2015 - Springer
Etanercept was the first tumour necrosis factor alpha antagonist approved in the USA for the
treatment of rheumatoid arthritis, in 1998, and then for other diseases. With the etanercept …

[HTML][HTML] Biosimilars in oncology: from development to clinical practice

KHR Tkaczuk, IA Jacobs - Seminars in oncology, 2014 - Elsevier
Biologics play an integral role in the treatment of cancer not only for their therapeutic effects
and ability to improve outcomes, but also as supportive care agents. Biologics are more …

Biopharmaceuticals for rheumatic diseases in Latin America, Europe, Russia, and India: innovators, biosimilars, and intended copies

G Castañeda-Hernández, Z Szekanecz, E Mysler… - Joint Bone Spine, 2014 - Elsevier
A biosimilar is a biopharmaceutical product intended to be comparable to a previously
licensed biopharmaceutical agent. The goal of such products is to increase the accessibility …

Monoclonal antibody and fusion protein biosimilars across therapeutic areas: a systematic review of published evidence

I Jacobs, D Petersel, LG Shane, CK Ng, C Kirchhoff… - BioDrugs, 2016 - Springer
Background Despite regulatory efforts to formalize guidance policies on biosimilars, there
remains a need to educate healthcare stakeholders on the acknowledged definition of …

[PDF][PDF] Current trends for biosimilars in the Latin American market

E Ortiz-Prado, J Ponce-Zea, JE Vasconez… - … Journal (GaBI Journal …, 2020 - researchgate.net
Biological medicines have become a major market for the pharmaceutical industry, the
biologicals market was valued at US $254.9 billion in 2017 and is expected to reach US …

Biosimilars for the next decade in Latin America: a window of opportunity

TG Bas - Expert Opinion on Biological Therapy, 2023 - Taylor & Francis
Introduction Biosimilars are gaining popularity in Latin America (LA). The biosimilars market
is expected to grow rapidly over the next decade as a cost-effective alternative to expensive …

Developing oncology biosimilars: an essential approach for the future

J Abraham - Seminars in Oncology, 2013 - Elsevier
The treatment of many diseases, particularly cancer, has been profoundly impacted by the
introduction of biologic therapies (biologics), which are incorporated into the treatment …