Results 181 to 190 of about 30,003 (287)
How the European Union reviews and approves ‘follow-on biologics’ or biosimilar products
Nicolas Rossignol
openalex +2 more sources
Generics, chemisimilars and biosimilars: is clinical testing fit for purpose? [PDF]
J. B. Warren
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Abstract The health economic value of insulin is usually expressed within a cost‐effectiveness framework providing an estimated incremental cost per quality‐adjusted life year (QALY) gained. Insulin clinical trials adopt a treat‐to‐target design in which both intervention and control arms aim to achieve similar levels of glycaemic control thereby ...
Phil McEwan, Marc Evans
wiley +1 more source
Biosimilars and the extrapolation of indications for inflammatory conditions
John RP Tesser,1 Daniel E Furst,2 Ira Jacobs3 1Arizona Arthritis & Rheumatology Associates, Phoenix, AZ, 2UCLA Health, Los Angeles, CA, 3Pfizer Inc, New York, NY, USA Abstract: Extrapolation is the approval of a biosimilar for use in an indication ...
Tesser JRP, Furst DE, Jacobs I
doaj
The role of biosimilars in the treatment of rheumatic diseases [PDF]
Thomas Dörner+9 more
openalex +1 more source
Coordinated regional action is urgently needed to safeguard insulin access in Asia amid global product realignment. This editorial emphasizes the ethical imperative and policy frameworks required to balance innovation with equitable, uninterrupted diabetes care.
Yutaka Seino+10 more
wiley +1 more source
Biosimilars: Company Strategies to Capture Value from the Biologics Market [PDF]
Bruno Calo-Fernández+1 more
openalex +1 more source
Presently available biosimilars in hematology-oncology: G-CSF [PDF]
Pere Gascón
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Background: treatment of erythropoietin (EPO) is essential in chronic kidney disease (CKD) patients to maintain optimal hemoglobin (Hb) level. Renogen is a biosimilar epoetin-α, and Eprex is the originator epoetin-α.
Ni Made Hustrini+3 more
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Opportunities and Challenges for Biosimilars: What's on the Horizon in the Global Insulin Market? [PDF]
Lisa S. Rotenstein+4 more
openalex +1 more source