Results 21 to 30 of about 9,605 (202)

Biosimilar: what it is not [PDF]

British Journal of Clinical Pharmacology, 2015
A biosimilar is a high quality biological medicine shown to be in essence the same as an original product. The European Medicines Agency (EMA) paved the way in the regulatory arena by creating a safeguarding framework for the development of biosimilars.
openaire   +2 more sources

Dose equivalency and efficacy of biosimilar erythropoietin stimulating agents: Data from real clinical practice

Pharmacology Research & Perspectives, 2020
Recently, biosimilar erythropoietin stimulating agents become available in Kazakhstan. Important properties of the biosimilar such as dose equivalency to the original medicine (originator) and the ability to maintain hemoglobin target levels remain ...
Abduzhappar Gaipov, Alpamys Issanov, Zhanar Mursalova, Nazia Tulegenova, Zoya Kakim, Mukhit Baizakov, Saltanat Tuganbekova, Mohamad Aljofan   +7 more
doaj   +1 more source

Science of Biosimilars [PDF]

Journal of Oncology Practice, 2017
Biosimilar therapeutic proteins in oncology offer the potential to decrease costs while providing safety and efficacy profiles consistent with their respective reference or originator products. Biosimilars have a number of important differences from generic small-molecule drugs, including manufacturing processes that are unique from their reference ...
openaire   +2 more sources

Biosimilars – terms of use [PDF]

Current Medical Research and Opinion, 2015
The impending expiry of the patent on a number of leading biologic drugs has led to a surge in the development of 'biosimilar' or 'follow-on' products. However, in contrast to generic small-molecule medicines, biosimilars are not identical to their reference products.
Declerck, Paul, Mellstedt, Håkan, Danese, Silvio   +2 more
openaire   +4 more sources

Changing trends in the use of anti-vascular endothelial growth factor (anti-VEGF) biosimilars: Insights from the Vitreoretinal Society of India Biosimilars of Anti-VEGF Survey

Indian Journal of Ophthalmology, 2021
Purpose: The aim of this study was to present the outcomes of the 2018 and 2020 Vitreo-retinal Society of India (VRSI) biosimilars of anti-vascular endothelial growth factor (VEGF) (VIBE) surveys.
Jay U Sheth, Michael W Stewart, Manoj Khatri, Shashank R Gupta, Shobhit Chawla, Anand Rajendran, Raja Narayanan   +6 more
doaj   +1 more source

Biosimilars in rheumatology

Pharmacological Research, 2019
Biotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide.
Araújo, Filipe C., Goncalves, Joao, Fonseca, João Eurico   +2 more
openaire   +3 more sources

Adoption of Biosimilar Infliximab for Rheumatoid Arthritis, Ankylosing Spondylitis, and Inflammatory Bowel Diseases in the EU5: A Budget Impact Analysis Using a Delphi Panel

Frontiers in Pharmacology, 2017
Introduction: Introducing biosimilar infliximab for the treatment in rheumatology (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohn's disease and ulcerative colitis) may reduce treatment costs associated with ...
Tim A. Kanters, Jelena Stevanovic, Jelena Stevanovic, Isabelle Huys, Arnold G. Vulto, Steven Simoens   +5 more
doaj   +1 more source

Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week‐24 Results of a Phase 3, Randomized, Placebo‐Controlled Study

Arthritis &Rheumatology, EarlyView.
Objective To evaluate the efficacy and safety of guselkumab, an interleukin‐23p19 subunit inhibitor, in participants with active psoriatic arthritis (PsA) and inadequate response (inadequate efficacy and/or intolerance) to one prior tumor necrosis factor (TNF) inhibitor.
Alexis Ogdie, Joseph F. Merola, Philip J. Mease, Christopher T. Ritchlin, Jose U. Scher, Kimberly Parnell Lafferty, Daphne Chan, Soumya D. Chakravarty, Wayne Langholff, Yanli Wang, Jie Shao, Yevgeniy Krol, Alice B. Gottlieb   +12 more
wiley   +1 more source

Population Pharmacokinetic Modeling of TV-46000, a Risperidone Long-Acting Subcutaneous Antipsychotic for the Treatment of Patients with Schizophrenia

Neurology and Therapy
Introduction TV-46000 is a long-acting subcutaneous antipsychotic (LASCA) agent that combines risperidone and an innovative, copolymer-based drug delivery technology in a suspension suitable for subcutaneous administration from a prefilled syringe.
Itay Perlstein, Avia Merenlender Wagner, Anna Elgart, Anthe S. Zandvliet, Farina Hellmann, YuWei Lin, Eline van Maanen, Nele Plock, Floris Fauchet, Rajendra Singh   +9 more
doaj   +1 more source

Coverage Generosity of Novel Antirheumatic Drugs in Medicare Advantage and Stand‐Alone Part D Plans

Arthritis &Rheumatology, EarlyView.
Objective We examine coverage of self‐administered disease‐modifying antirheumatic drugs (DMARDs) in Medicare Part D. Methods Using 2022–2026 Part D formulary data, we assessed coverage of the following DMARD classes that treat relapsed rheumatoid arthritis (RA): tumor necrosis factor (TNF) inhibitors, T cell costimulatory modulator, interleukin‐6 (IL ...
Youngmin Kwon, Robert W. Corty, Stacie B. Dusetzina   +2 more
wiley   +1 more source