Results 101 to 110 of about 39,064 (303)

Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices

open access: yesPharmaceuticals, 2021
Background: In Europe, off-patent biologicals and biosimilars are largely procured by means of tender procedures. The organization and design of tenders may play a key role in the evolving biosimilar market, and currently, it is not fully elucidated how ...
L. Barbier   +5 more
semanticscholar   +1 more source

Techno‐Economic Analysis of Membrane‐Based Purification Platforms for AAV Vector Production

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT Technologies for large‐scale manufacturing of viral vectors for gene therapies, such as tangential flow filtration and membrane chromatography, are under development. In these early stages of process development, techno‐economic analyses are useful for identifying membrane properties yielding the greatest impact on process performance. In this
Juan J. Romero   +6 more
wiley   +1 more source

The process defines the product: what really matters in biosimilar design and production? [PDF]

open access: yes, 2017
Biologic drugs are highly complex molecules produced by living cells through a multistep manufacturing process. The key characteristics of these molecules, known as critical quality attributes (CQAs), can vary based on post-translational modifications ...
Jaquez, O.A. (Orlando A.)   +1 more
core   +8 more sources

Evaluating the benefits of TNF-alfa inhibitor biosimilar competition on off-patent and on-patent drug markets: A Southern European analysis

open access: yesFrontiers in Pharmacology, 2022
Background: The level of competition achieved following biosimilars market availability varies by country, care setting and molecule. Hence, biosimilars contribution to attaining price reductions and extended access to treatments can also vary.Objective:
Teresa Barcina Lacosta   +4 more
doaj   +1 more source

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

open access: yes, 2016
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
core   +2 more sources

Biosimilars and cancer treatment of older patients [PDF]

open access: yes, 2016
Biosimilar monoclonal antibodies are being developed globally to meet clinical demand in oncology and potentially provide greater access to biologic therapies for patients with cancer, including older patients.
Jacobs, Ira A.   +2 more
core   +1 more source

A Surface Plasmon Resonance‐Based Integrated Assay for Quantification and Glycosylation Characterization of Monoclonal Antibodies in Crude Heterogeneous Samples

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT The rise in cancer, autoimmune, inflammatory, and infectious diseases in recent decades has led to a surge in the development of monoclonal antibodies (mAbs) therapies, now the most widely used family of biologics. To meet the growing global demand, biopharmaceutical industries are intensifying their production processes.
Ilona Metayer   +7 more
wiley   +1 more source

Knowledge and attitudes of German and Swiss community pharmacists towards biologicals and biosimilars – a prospective survey before and after the COVID-19 pandemic

open access: yesBMC Health Services Research, 2023
Background Knowledge, attitudes and substitution laws of biosimilars are not consistent across countries. Biosimilar acceptance among patients and healthcare professionals may be suffering from gaps in knowledge and understanding about biosimilars and ...
Kirstin Messner   +4 more
doaj   +1 more source

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results [PDF]

open access: yes, 2017
Background: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy,
Argüelles Arias, Federico   +7 more
core  

Biosimilar infliximab introduction into the gastro-enterology care pathway in a large acute Irish teaching hospital: a story behind the evidence [PDF]

open access: yes, 2018
Background and aim: Biosimilar medicines are not considered exact replicas of originator biological medicines. As a result, prescribers can be hesitant to introduce such medicines into the clinical setting until evidence surfaces confirming their safety ...
Byrne, Stephen   +5 more
core   +1 more source

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