Results 1 to 10 of about 693,400 (226)
Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region.
Evelien Moorkens +8 more
doaj +2 more sources
Addressing the health technology assessment of biosimilar pharmaceuticals
Abstract The growing number of biosimilars presents challenges to regulatory and health technology assessment (HTA) systems. This paper illustrates these challenges by focusing on biosimilars used in the oncological setting. In particular, discordances between data required by regulatory and HTA authorities potentially deprive patients of effective ...
A. Stewart, P. Aubrey, J. Belsey
semanticscholar +3 more sources
Slow uptake of biosimilars in some regions is often attributed to a lack of knowledge combined with concerns about safety and efficacy. To alleviate physician and patient apprehensions, regulatory reviews from four major regulatory authorities (RAs ...
Beverly Ingram +3 more
doaj +2 more sources
Exploring Stakeholder Perceptions and Experience of Biosimilar Insulin Switching: A Scoping Review [PDF]
Background The option to switch patients to more cost‐effective biosimilar insulins has been available since 2014, and the market share for these medicines has been slowly increasing since then. This scoping review aimed to identify the current knowledge
Ben Hindley +4 more
doaj +2 more sources
Purpose: The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular ...
Lalit Verma +5 more
doaj +2 more sources
Analytical similarity as the primary determinant of monoclonal antibody development: toward evidence-efficient regulatory frameworks [PDF]
Monoclonal antibodies (mAbs) constitute the most rapidly expanding and therapeutically impactful class of biological medicines, driven by their exceptional target specificity, modular engineering capabilities, predictable pharmacokinetics facilitated by ...
Sarfaraz K. Niazi
doaj +2 more sources
Expected Impact of Biosimilars on the Pharmaceutical Companies.
In the last three decades, biological products have gradually developed to be an essential basis in the pharmaceutical industry. Advancements in this field have encouraged the frontiers of science to bring life-saving treatments to patients suffering from incurable diseases, such as cancers and has also assisted clinicians in managing chronic diseases ...
Golshani, Shiva, Faramarzi, Mohammad Ali
openaire +3 more sources
Policies to Encourage the Use of Biosimilars in European Countries and Their Potential Impact on Pharmaceutical Expenditure [PDF]
Introduction: Biosimilar medicines are considered promising alternatives to new biologicals with high price tags. The extent of savings resulting from biosimilar use depends on their price and uptake, which are largely shaped by pricing, reimbursement, and demand-side policies.
Vogler, Sabine +4 more
openaire +4 more sources
Background: Limited pharmacotherapy and the failure of conventional treatments in complex pathologies in children lead to increased off-label use of rituximab.
Natalia Riva +10 more
doaj +1 more source
Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models [PDF]
Purpose: To evaluate the toxicity of Erbitux as well as its biosimilar APZ001 antibody (APZ001) in pre-clinical animal models including mice, rabbits and cynomolgus monkeys.
Xiaofei Wang +7 more
doaj +2 more sources

