The Global Landscape of Manufacturers of Follow-on Biologics: An Overview of Five Major Biosimilar Markets and 15 Countries
ConclusionsWith this study, we try to contribute to discussions on creating more transparency about global approvals of follow-on biologics and promoting access to high-quality biosimilars in countries around the world. (Source: BioDrugs)
Source: BioDrugs - December 6, 2022 Category: Drugs & Pharmacology Source Type: research
Translational Approach for Predicting Human Pharmacokinetics of Engineered Therapeutic Monoclonal Antibodies with Increased FcRn-Binding Mutations
ConclusionsWe found that engineered mAbs require specially optimized exponents to accurately predict pharmacokinetic parameters and plasma concentration –time profiles after IV injections in humans based on cynomolgus monkey data. This optimized approach can contribute to a more accurate prediction of human pharmacokinetics in the development of engineered mAbs. (Source: BioDrugs)
Source: BioDrugs - November 30, 2022 Category: Drugs & Pharmacology Source Type: research
Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial
ConclusionsPharmacokinetic similarity between BAT2206 and ustekinumab (USA or European Union sourced) was confirmed. The three groups had similar safety profiles, and the investigational drugs were well tolerated by subjects.Clinical Trial RegistrationThis study was registered with ClinicalTrials.gov (NCT04371185). (Source: BioDrugs)
Source: BioDrugs - November 22, 2022 Category: Drugs & Pharmacology Source Type: research
Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database (VigiBase ®)
ConclusionWe identified possible associations with some adverse fetal and neonatal outcomes, suggesting that vigilance is required when prescribing certain biologics during pregnancy. (Source: BioDrugs)
Source: BioDrugs - November 19, 2022 Category: Drugs & Pharmacology Source Type: research
Correction to: First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data
(Source: BioDrugs)
Source: BioDrugs - November 19, 2022 Category: Drugs & Pharmacology Source Type: research
Fetal and Neonatal Adverse Drug Reactions Associated with Biologics Taken During Pregnancy by Women with Autoimmune Diseases: Insights from an Analysis of the World Health Organization Pharmacovigilance Database (VigiBase ®)
ConclusionWe identified possible associations with some adverse fetal and neonatal outcomes, suggesting that vigilance is required when prescribing certain biologics during pregnancy. (Source: BioDrugs)
Source: BioDrugs - November 19, 2022 Category: Drugs & Pharmacology Source Type: research
Correction to: First-Line Treatment of Advanced Non-Small-Cell Lung Cancer with Immune-Checkpoint Inhibitors: New Combinations and Long-Term Data
(Source: BioDrugs)
Source: BioDrugs - November 19, 2022 Category: Drugs & Pharmacology Source Type: research
Lower Limbs are the Most Difficult-to-Treat Body Region of Patients with Psoriasis: Pooled Analysis of CLEAR and CLARITY Studies of Secukinumab Versus Ustekinumab by Body Region
ConclusionsLower limbs were the most severely affected and most difficult-to-treat regions in patients with psoriasis. Consistent with the individual results of both studies, secukinumab demonstrated numerically faster and higher skin clearance than ustekinumab in all body regions.Clinical Trial RegistrationCLEAR: NCT02074982; CLARITY: NCT02826603. (Source: BioDrugs)
Source: BioDrugs - November 5, 2022 Category: Drugs & Pharmacology Source Type: research
Rheumatoid Arthritis Treatment Options and Type 2 Diabetes: Unravelling the Association
AbstractMultiple lines of evidence have increasingly suggested a pathogenic connection between rheumatoid arthritis (RA) and the mechanisms of type 2 diabetes (T2D) in a vicious circle perpetuated by glucose derangement and inflammatory mediators. These findings have been further reinforced by clinical studies showing that the inhibition of interleukin (IL)-1 and IL-6 may allow the treatment of RA and concomitant T2D at the same time. Interestingly, IL-1 inhibition induced a more evident reduction of glycated haemoglobin (HbA1c) in patients with concomitant RA and T2D than in previous studies on IL-1 inhibition in patients...
Source: BioDrugs - November 2, 2022 Category: Drugs & Pharmacology Source Type: research
Assessing Immunogenicity of Biologic Drugs in Inflammatory Joint Diseases: Progress Towards Personalized Medicine
AbstractBiologic drugs have greatly improved treatment outcomes of inflammatory joint diseases, but a substantial proportion of patients either do not respond to treatment or lose response over time. Drug immunogenicity, manifested as the formation of anti-drug antibodies (ADAb), constitute a significant clinical problem. Anti-drug antibodies influence the pharmacokinetics of the drug, are associated with reduced clinical efficacy, and an increased risk of adverse events such as infusion reactions. The prevalence of ADAb differs among drugs and diseases, and the detection of ADAb also depends on the assay format. Most data...
Source: BioDrugs - October 31, 2022 Category: Drugs & Pharmacology Source Type: research
