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Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

open access: yesPharmaceuticals, 2020
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

open access: yesCurrent Medical Research and Opinion, 2010
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

Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities

open access: yesPharmaceuticals, 2021
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]

open access: yesEndocrinology, Diabetes & Metabolism
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

Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab

open access: yesIndian Journal of Ophthalmology, 2021
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]

open access: yesFrontiers in Drug Delivery
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.

open access: yesIranian journal of medical sciences, 2021
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]

open access: yesFrontiers in Pharmacology, 2021
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

Population Pharmacodynamic Modelling of the CD19+ Suppression Effects of Rituximab in Paediatric Patients with Neurological and Autoimmune Diseases

open access: yesPharmaceutics, 2023
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]

open access: yesActa Cirúrgica Brasileira, 2018
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

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