Results 11 to 20 of about 40,241 (253)
Do the Outcomes of Clinical Efficacy Trials Matter in Regulatory Decision-Making for Biosimilars?
BioDrugs, 2023 There is an increasing body of evidence supporting a more flexible approach in clinical data requirements for the approval of more complex biosimilar substances such as monoclonal antibodies (mAbs). The aim of this paper is to further analyse the role of
Nadine Kirsch-Stefan +7 more
semanticscholar +1 more source
Rheumatology International, 2014 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 patent set to expire in the EU in 2015, a number of etanercept copies have reached the production phase and are undergoing clinical trials, with the promise of being ...
Azevedo, Valderilio F. +4 more
openaire +2 more sources
ANTI–VASCULAR ENDOTHELIAL GROWTH FACTOR BIOSIMILARS IN OPHTHALMOLOGY
Retina, 2022 Statement: Anti–vascular endothelial growth factor biosimilars in ophthalmology are expected to enter the United States and European markets in the coming years.
P. Kaiser +2 more
semanticscholar +1 more source
Future of anti-VEGF: biosimilars and biobetters
International Journal of Retina and Vitreous, 2022 The advent of Anti- VEGFs like Lucentis (Ranibizumab), Eylea (Aflibercept) and off-label Avastin (Bevacizumab) have radically improved visual outcomes in patients of neovascular Age Related Macular Degeneration (nARMD), Diabetic Macular Edema (DME) and ...
Monika Kapur, Suvansh Nirula, M. Naik
semanticscholar +1 more source
Therapeutische Umschau, 2011 Die Bewertung von Biosimilars stellt eine Herausforderung für alle an der Zulassung und an der Arzneimittelauswahl Beteiligten im Gesundheitswesen dar. Bewertungskriterien sind wie bei allen Arzneimitteln Qualität, Wirksamkeit, Sicherheit/Verträglichkeit und Wirtschaftlichkeit.
openaire +6 more sources
Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer
Biomedicines, 2022 Trastuzumab is a monoclonal antibody used in the treatment of breast cancer in cases where the tumor overexpresses the HER2 receptor, a cell membrane receptor activated by the epidermal growth factor.
E. Triantafyllidi, J. Triantafillidis
semanticscholar +1 more source
Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland
JAMA Network Open, 2022 Key Points Question How do uptake and prices of biosimilars in the US compare with 2 European countries (Germany and Switzerland) with national mechanisms for drug price negotiation?
D. L. Carl +5 more
semanticscholar +1 more source
Switching Among Biosimilars: A Review of Clinical Evidence
Frontiers in Pharmacology, 2022 Biological medicines have improved patients’ outcomes, but their high costs may limit access. Biosimilars, alternatives that have demonstrated high similarity in terms of quality, safety, and efficacy to an already licensed originator biological product,
Eleonora Allocati +4 more
semanticscholar +1 more source
BioDrugs, 2022 The World Health Organization (WHO) guidelines on evaluation of similar biotherapeutic products (SBPs; also called biosimilars) were adopted by the WHO Expert Committee on Biological Standardization (ECBS) in 2009.
P. Kurki +5 more
semanticscholar +1 more source
The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway? [PDF]
, 2008 The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate.
Kaldre, Ingrid
core +4 more sources