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We investigated the off-patent biological market in Belgium from a policy maker's perspective, in light of the Belgian pharmaceutical health system. The main barriers relate to a short-term budgetary focus, to the overwhelming innovator's reach and to a concertation model with assessment and appraisal being mixed which results in poorly effective policy measures.
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http://dx.doi.org/10.3390/ph14040352 | DOI Listing |
Trials
August 2025
Copenhagen Research Center for Biological and Precision Psychiatry, Mental Health Center Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark.
Background: Globally, depression represents one of the leading causes of years lived with disability. The effects of current pharmacological treatments are small-to-moderate and often delayed by weeks. Immunological disturbances have been associated with depression and meta-analyses have suggested that anti-inflammatory agents have moderate-to-large anti-depressant effects.
View Article and Find Full Text PDFBr J Cancer
September 2025
Medical Oncology Group, Division of Cancer Research, Dundee, UK.
Background: Oesophageal squamous cell carcinoma (ESCC) is associated with late-stage diagnosis, limited treatment options, the development of drug resistance and poor outcome. Epidermal growth factor receptor is frequently dysregulated in ESCC. EGFR copy number gain and/or protein overexpression are beneficial as predictive biomarkers for EGFR inhibitor therapy; however, inherent and acquired resistance limit response rates, and durable disease control is infrequent.
View Article and Find Full Text PDFMicrobiol Spectr
August 2025
Department of Microbiology and Immunology, Emory University School of Medicine, Atlanta, Georgia, USA.
The obligate human pathogen (also known as GAS; Group A ) carries high morbidity and mortality, primarily in impoverished or resource-poor regions. The failure rate of monotherapy with conventional antibiotics is high, and invasive infections by this bacterium frequently require extensive supportive care and surgical intervention. Thus, it is important to find new compounds with adjunctive therapeutic benefits.
View Article and Find Full Text PDFBioDrugs
July 2025
Comparative Outcomes Group, Bristol, UK.
The introduction of biosimilars into healthcare systems globally is recognized by many as a healthcare success. Despite this, questions have been raised about whether biosimilars can deliver sufficient value to patients and healthcare professionals, as well as sufficient cost saving, for their use in treatment to be worthwhile. In this review, we discuss how the increasing financial burden of complex therapeutic medicines, such as biologics, can be ameliorated by off-patent biosimilar medicines, particularly with increasing worldwide incidences of cancer and other chronic diseases.
View Article and Find Full Text PDFValue Health Reg Issues
September 2025
Italian Medicines Agency, Rome, Italy.
Objectives: There is a paucity of evidence around the true economic value of biosimilars, especially in the long term. The aim of this study was to estimate the biosimilars uptake, cost trends of off-patent biologics and savings generated through the use of biosimilars in the Italian National Health Service in the 2013 to 2022 period.
Methods: We identified all biologics (ie, reference products) and related biosimilars that were approved in Europe and marketed in Italy until December 2022.