The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: a systematic review
To date, no consensus exists among stakeholders about switching patients between
reference biological products (RPs) and biosimilars, which may have been curbing the …
reference biological products (RPs) and biosimilars, which may have been curbing the …
The challenge of modulating β-cell autoimmunity in type 1 diabetes
MA Atkinson, BO Roep, A Posgai… - The Lancet Diabetes & …, 2019 - thelancet.com
With the conceptual advance about four decades ago that type 1 diabetes represents an
autoimmune disease, hope arose that immune-based therapies would soon emerge to …
autoimmune disease, hope arose that immune-based therapies would soon emerge to …
Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: a regulatory perspective
P Kurki, S Barry, I Bourges, P Tsantili, E Wolff-Holz - Drugs, 2021 - Springer
Background Biosimilars have been used for 15 years in the European Union (EU), and have
been shown to reduce costs and increase access to important biological medicines. In spite …
been shown to reduce costs and increase access to important biological medicines. In spite …
Regulation of biosimilar medicines and current perspectives on interchangeability and policy
J O'Callaghan, SP Barry, M Bermingham… - European journal of …, 2019 - Springer
Competition arising from the increasing availability of biosimilar medicines has resulted in
healthcare savings and has provided greater patient access to high cost therapeutics in …
healthcare savings and has provided greater patient access to high cost therapeutics in …
The importance of countering biosimilar disparagement and misinformation
HP Cohen, D McCabe - BioDrugs, 2020 - Springer
Biosimilar use is limited in some healthcare systems because biosimilars are not well
understood by many healthcare professionals and patients. The knowledge gap is …
understood by many healthcare professionals and patients. The knowledge gap is …
Efficacy and safety of adalimumab biosimilars: current critical clinical data in rheumatoid arthritis
XQ Lu, R Hu, L Peng, MS Liu, Z Sun - Frontiers in Immunology, 2021 - frontiersin.org
Adalimumab, as a TNF inhibitor biologic for the treatment of rheumatoid arthritis, is one of
the top-selling drugs worldwide. As its various patents have gradually expired, experiments …
the top-selling drugs worldwide. As its various patents have gradually expired, experiments …
[HTML][HTML] Are we ready to close the discussion on the interchangeability of biosimilars?
HC Ebbers, H Schellekens - Drug Discovery Today, 2019 - Elsevier
Highlights•There are different regulatory approaches toward interchanging
biosimilars.•Blinded clinical studies do not reflect switching in clinical practice.•Current data …
biosimilars.•Blinded clinical studies do not reflect switching in clinical practice.•Current data …
The automatic substitution of biosimilars: Definitions of interchangeability are not interchangeable
A Afzali, D Furtner, R Melsheimer, PJ Molloy - Advances in Therapy, 2021 - Springer
In the USA, an interchangeability designation provides biosimilar sponsors with a pathway
for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution …
for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution …
Patient attitudes about non-medical switching to biosimilars: results from an online patient survey in the United States
A Teeple, S Ginsburg, L Howard, L Huff… - … medical research and …, 2019 - Taylor & Francis
Objective: To evaluate patient attitudes regarding non-medical switching (NMS) to
biosimilars among patients with autoimmune disease currently receiving a biologic …
biosimilars among patients with autoimmune disease currently receiving a biologic …
Therapeutic equivalence of biosimilar and reference biologic drugs in rheumatoid arthritis: A systematic review and meta-analysis
B de Oliveira Ascef, MO Almeida… - JAMA Network …, 2023 - jamanetwork.com
Importance Biosimilar drugs are potentially lower-cost versions of biologics that may
improve access to therapy. However, there is a lack of adequate systematic reviews …
improve access to therapy. However, there is a lack of adequate systematic reviews …