BioDrugs Journal

This manuscript evaluated the impact of demand- and supply-side policies on biosimilar market penetration and identified effective strategies for promoting biosimilar uptake in eight high-income countries. #biosimilars #marketpenetration #OpenAccess link.springer.com/article/10.100…

This study evaluated quality attributes of multiple lots of reference products and their biosimilars approved in Japan. #biosimilars #qualityattributes #openaccess link.springer.com/article/10.100…

This review presents current and future treatment options for Fabry disease, with advantages and disadvantages of the different treatment options. #FabryDisease #genetherapy #OpenAccess link.springer.com/article/10.100…

This study investigates the structural origins and functional implications of charge heterogeneity in two therapeutic IgG2 antibodies using free-flow isoelectric focusing (FF-IEF). #chargevariants #monoclonalantibodies #isoelectricfocusing link.springer.com/article/10.100…

This narrative review provides insights into the efficacy and safety of transitioning to and among adalimumab biosimilars in adult patients from clinical studies and real-world evidence from outside the USA. #biosimilars #adalilumab #realworldevidence link.springer.com/article/10.100…

This review summarizes the recent advances in the knowledge of IgM biogenesis and structure and discusses the therapeutic opportunities of IgM over IgG and outstanding challenges. #antibody #immunoglobulinM #monoclonalAntibodies link.springer.com/article/10.100…

This study provides real-world evidence on the effectiveness and safety of spesolimab treatment for GPP flares, based on a case series of Portuguese patients. #GeneralizedPustularPsoriasis #spesolimab #il36 rdcu.be/ejAH2

This article highlights the evolution of nucleic acid-based drug development, focusing on the pioneering agents fomivirsen, patisiran, & givosiran, & discusses the ongoing challenges in advancing these therapeutics & vaccines #nucleicaciddrugs #genetherapy bit.ly/3REq7wS

CM326 is a novel monoclonal antibody targeting TSLP under investigation for the treatment of several type 2 inflammatory diseases. This study presents preclinical characterization and phase I human trials. #thymicstromallymphopoietin #inflammatorydisease bit.ly/4kclshZ

In this cohort study of older patients with immune-mediated inflammatory diseases, Gianluca Trifirò et al found a 6-fold increase in use of biologics from 2010 to 2022, and a treatment persistence of ~50% at one year. #OpenAccess #biologics #olderadults link.springer.com/article/10.100…

This study investigated the clinical safety, tolerability, pharmacokinetics & preliminary pharmacodynamics of HEC88473, a 2nd generation GLP-1/FGF21 agonist, in a phase I, single-ascending dose trial with healthy & obese subjects #glp1 #FGF21 #FirstInHuman link.springer.com/article/10.100…

Torleif Tollefsrud Gjølberg and colleagues describe FcRn biology, and give an overview of the current clinical pipeline of FcRn antagonists in autoimmune diseases. #neonatalFcReceptor #autoimmunedisease #OpenAccess link.springer.com/article/10.100…

This review focuses on the biogenesis of extracellular vesicles (EVs), their role in transplant immunology, and how immunosuppressive drugs might influence these processes. #extracellularvesicles #organtransplant #transplantrejection #OpenAccess link.springer.com/article/10.100…

This review explores the basic structure, preclinical principles, clinical trial progress, and challenges of multispecific antibodies targeting PD-1/PD-L1 in tumor therapy. #multispecificantibodies #BispecificAntibodies #CancerImmunotherapy link.springer.com/article/10.100…

Structure activity relationship studies of the biosimilar BAT1806/BIIB800 and reference tocilizumab were conducted to assess the potential impact of observed minor differences in quality attributes #biosimilarity #Structureactivity #Tocilizumab #openaccess link.springer.com/article/10.100…

Findings from a targeted review have been incorporated into a framework of biosimilar market sustainability dimensions, to be used by stakeholders in decision-making to ensure long-term viability of the market. #Biosimilar #biosimilarmarket #sustainability link.springer.com/article/10.100…

This analysis reviewed biosimilar-promoting policies in 13 OECD countries and examined their impact on biosimilar uptake and expenditure reduction for adalimumab, etanercept, and infliximab. #biosimilar #tendering #HealthcarePolicy #healthcarecosts link.springer.com/article/10.100…

This review highlights the importance of biosimilars of reference eculizumab and their entry for use in patients with paroxysmal nocturnal hemoglobinuria or atypical hemolytic uremic syndrome. #Biosimilar #eculizumab #openaccess link.springer.com/article/10.100…

Alfredo Addeo & colleagues review proposed mechanisms of resistance to immunotherapy with checkpoint inhibitors, & discuss therapeutic strategies designed to prevent primary resistance and counteract acquired resistance. #immunotherapy #NSCLC #OpenAccess bit.ly/4k2Wwdh

Arthur Rech Tondin & Giacomo Lanzoni provide an overview of current islet replacement strategies for type 1 diabetes, ranging from islet transplantation to stem cell-derived islet cell transplantation. #diabetes #isletcell #celltherapy #OpenAccess link.springer.com/article/10.100…