There is no doubt that biologic therapies provide added value for health systems. However, due to their special nature, they also raise some questions that make highly rigorous and demanding quality control and monitoring of their use indispensable. This circumstance is reinforced with the appearance on the scene of biosimilars, which, given their lower cost, are having an increasing impact on the international market. The purpose of this article is to review the major issues posed by their manufacture, distribution and control systems, as well as the most important aspects related to their safety in clinical practice. In this report, we assess the pharmacovigilance of these products, with special attention to traceability, as a key tool to enable earlier detection of adverse events.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.reuma.2016.05.013 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Evaluating convalescent plasma therapy in severe COVID-19: a retrospective cohort study.
J Infect Dev Ctries
December 2024
Department of Pharmacology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.
Introduction: Convalescent plasma (CP) therapy is a form of passive immunization which has been used as a treatment for coronavirus disease 2019 (COVID-19). This study aims to evaluate the efficacy and safety of CP therapy in patients with severe COVID-19.
Methodology: In this retrospective cohort study, 50 patients with severe COVID-19 treated with CP at Shahid Beheshti Hospital, Kashan, in 2019 were evaluated.
Hospital attendance, malaria prevalence and self-medication with an antimalarial drug before and after the start of COVID-19 pandemic in a sentinel site for malaria surveillance in Gabon.
Malar J
January 2025
Department of Parasitology-Mycology and Tropical Medicine, Université Des Sciences de La Santé de Libreville, BP 4009, Libreville, Gabon.
Background: The negative impact of COVID-19 pandemic on healthcare service utilization has been reported in several countries. In Gabon, data on the preparedness for future pandemic are lacking. The aim of the present study was to assess the trends of hospital attendance, malaria and self-medication prevalences as well as ITN use before and during Covid-19 first epidemic waves in a paediatric wards of a sentinel site for malaria surveillance, in Libreville, Gabon.
View Article and Find Full Text PDFComparative evaluation of allograft particulate bone and cortical bone blocks combined with xenograft bone for labial bone defects in the aesthetic zone: a prospective cohort study.
BMC Oral Health
January 2025
State Key Laboratory of Oral Diseases & National Clinical Research Center for Oral Diseases & Department of Implant Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu, 610041, China.
Purpose: This study aimed to evaluate the osteogenic performance of allograft particulate bone and cortical bone blocks combined with xenograft under bovine pericardium membranes, for treating different degrees of labial bone defects in the aesthetic zone.
Materials And Methods: Twenty-four patients with bone defects were divided into two groups based on defect severity (Terheyden 1/4 and 2/4 groups). The Terheyden 1/4 group received granular bone grafts alone, while the Terheyden 2/4 group received cortical bone blocks combined with granular bone grafts.
Synergistic anticancer effects of cisplatin and phenolic aglycones of the aerial part of Rumex dentatus L. in tongue squamous cell carcinoma: insights from network pharmacology and biological verification.
BMC Complement Med Ther
January 2025
Department of Biochemistry, Faculty of Pharmacy, Tanta University, Tanta, 31527, Egypt.
Background: Oral squamous cell carcinoma (OSCC) ranks as the sixth most common malignancy globally. Cisplatin is the standard chemotherapy for OSCC, but resistance often reduces its efficacy, necessitating new treatments with fewer side effects. Rumex dentatus L.
View Article and Find Full Text PDFIntestinal obstruction caused by disseminated mycobacterium avium complex disease following solid organ transplantation: a case report.
BMC Infect Dis
January 2025
Department of Respiratory Medicine, Faculty of Medicine, Hokkaido University, North 15 West 7, Kita-ku, Sapporo, 060-8638, Japan.
Background: Mycobacterium avium complex (MAC) is a common pathogen causing non-tuberculous mycobacterial infections, primarily affecting the lungs. Disseminated MAC disease occurs mainly in immunocompromised individuals, such as those with acquired immunodeficiency syndrome, hematological malignancies, or those positive for anti-interferon-γ antibodies. However, its occurrence in solid organ transplant recipients is uncommon.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!