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Cost-effectiveness analysis of subcutaneous biosimilar tocilizumab in patients with rheumatoid arthritis in Spain.
Farm Hosp
December 2024
Hospital Universitario Doctor Peset, Valencia, Spain. Electronic address:
Introduction: Rheumatoid arthritis (RA) is the most common chronic inflammatory rheumatic disease, its management and morbidity impose a great burden to healthcare systems. Development and rollout of biological disease modifying anti-rheumatic drugs has contributed to improvements for patients, however, high costs have prevented them to be widely used. This is being addressed with biosimilars, with equal benefit-risk profile and reduced costs.
View Article and Find Full Text PDFAn Educational Digital Tool to Improve the Implementation of Switching to a Biosimilar (Rapid Switch Trainer): Tool Development and Validation Study.
JMIR Form Res
November 2024
Medical Department, Sandoz Farmacéutica, Madrid, Spain.
Background: Switching to biosimilars is an effective and safe practice in treating inflammatory diseases; however, a nocebo effect may arise as a result of the way in which the switch is communicated to a given patient.
Objective: We aimed to design a gaming-based digital educational tool (including a discussion algorithm) to support the training of health care professionals in efficiently communicating the switch to biosimilars, minimizing the generation of a nocebo effect and thus serving as an implementation strategy for the recommended switch.
Methods: The tool was developed based on interviews and focus group discussions with key stakeholders, both patients and health care professionals.
In-Use Physicochemical Stability of Sandoz Rituximab Biosimilar in 0.9% Sodium Chloride Solution After Prolonged Storage at Room Temperature Conditions.
Drugs R D
December 2024
Medical Oncology, Sandoz GmbH, Holzkirchen, Germany.
Article Synopsis
- This study examined the stability of Sandoz rituximab biosimilar (SDZ-RTX) under various storage conditions, focusing on both in-use and out-of-fridge scenarios to ensure patient safety.
- The researchers subjected two SDZ-RTX batches to long-term refrigeration followed by exposure to higher temperatures and humidity to simulate real-world storage situations.
- Results indicated that SDZ-RTX maintained its physicochemical and biological quality, meeting strict acceptance criteria even after exposure to elevated temperatures, provided it was prepared in a sterile environment.
Nonclinical Similarity of the Biosimilar Candidate ABP 938 with Aflibercept Reference Product.
Ophthalmol Ther
November 2024
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Introduction: ABP 938 is being developed as a biosimilar to Eylea (aflibercept reference product [RP]), an anti-vascular endothelial growth factor (VEGF) drug used in the management of retinal diseases. Previously, a comparative analytical similarity assessment demonstrated that ABP 938 and aflibercept RP have the same amino acid sequence and exhibit similar higher-order structure and biological activity. The nonclinical studies described here were designed to assess the in vitro pharmacology and the in vivo pharmacokinetics (PK), toxicokinetics (TK), and safety profiles of ABP 938 compared to aflibercept RP.
View Article and Find Full Text PDFLabel-free assessment of complement-dependent cytotoxicity of therapeutic antibodies via a whole-cell MALDI mass spectrometry bioassay.
Sci Rep
September 2024
Center for Mass Spectrometry and Optical Spectroscopy (CeMOS), Mannheim University of Applied Sciences, Paul-Wittsack-Str. 10, 68163, Mannheim, Germany.
Potency assessment of monoclonal antibodies or corresponding biosimilars in cell-based assays is an essential prerequisite in biopharmaceutical research and development. However, cellular bioassays are still subject to limitations in sample throughput, speed, and often need costly reagents or labels as they are based on an indirect readout by luminescence or fluorescence. In contrast, whole-cell Matrix-Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) Mass Spectrometry (MS) has emerged as a direct, fast and label-free technology for functional drug screening being able to unravel the molecular complexity of cellular response to pharmaceutical reagents.
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