Results 71 to 80 of about 30,003 (287)
Biotechnology Progress, EarlyView.Abstract Continuous manufacturing platforms and membrane chromatography are process technologies with the potential to reduce production costs and minimize process variability in monoclonal antibody production. This study presents a simulation and optimization framework to perform techno‐economic analyses of these strategies.
Juan J. Romero +3 more
wiley +1 more source
Clinical Medicine Insights: OncologyBackground: The bevacizumab biosimilar (Encoda), which was approved by the National Medical Products Administration (NMPA) in China in 2019, is a biosimilar of bevacizumab.
Han Shan +5 more
doaj +1 more source
Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA
Биопрепараты: Профилактика, диагностика, лечение, 2019 European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul ...
A. A. Soldatov +3 more
doaj +1 more source
Biosimilar insulins: Narrative review of the regulatory framework and registration studies. [PDF]
Diabetes Obes MetabAbstract Biosimilar insulins have been commercially available in the EU since 2014. Currently, six biosimilar insulins are approved in the EU and four in the US. However, commercial success has been limited, which may be in part due to concerns among physicians and people with diabetes that biosimilar insulins are substandard in efficacy, safety, and ...
Heise T, DeVries JH.
europepmc +2 more sources
Optimization of multi‐column chromatography for capture and polishing at high protein load
Biotechnology Progress, EarlyView.Abstract Integrated Continuous Biomanufacturing reduces manufacturing costs while maintaining product quality. A key contributor to high biopharmaceutical costs, specifically monoclonal antibodies (mAbs), is chromatography. Protein A ligands are usually preferred but still expensive in the manufacturing context, and batch chromatography under‐utilizes ...
Tiago Castanheira Silva +4 more
wiley +1 more source
Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland [PDF]
, 2017 Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in ...
Bermingham, Margaret +6 more
core +1 more source
Proceedings of the National Academy of Sciences, 2015 The development of biosimilars should have a big impact on patients, insurers, and pharmaceutical companies for years to come. Image courtesy of Shutterstock/Sasa Komlen.
openaire +3 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 P, Mellstedt H, Danese S
openaire +4 more sources
Epoetin Biosimilars in the Treatment of Chemotherapy-Induced Anemia: 10 Years' Experience Gained. [PDF]
, 2018 High-quality, safe, and effective biosimilars have the potential to increase access to biological therapies worldwide and to reduce cancer care costs.
Aapro, Matti +3 more
core +1 more source
The Inflation Reduction Act and Etanercept
Arthritis &Rheumatology, EarlyView.
Charles L. Bennett +6 more
wiley +1 more source