The Biosimilar Interchangeability Wrinkle The expansion of Cost Plus into biosimilars introduces a complication specific to the biologics market: interchangeability
Natl Toxicol Prog Tech Rep Ser 540:1224 Dominik JS, Paul WB, Abdu IA, John DB, Gregory MV (2013) Hemolysis and free hemoglobin revisited: exploring hemoglobin and hemin scavengers as a novel class of therapeutic proteins
Not approved by the FDA for any consumer or clinical application outside its approved Scenesse indication
( The safety profile of liraglutide in our cohort was consistent with previous pediatric randomized controlled trials (RCTs), with adverse events (AEs) predominantly mild and gastrointestinal in nature, including nausea, vomiting, and diarrhea, reported in 43.6% of participants ( Despite these favorable outcomes, the discontinuation rate during the dose-escalation phase was relatively high (25.6%), mirroring patterns observed in other pediatric liraglutide trials where treatment withdrawal often occurred during the initial weeks, coinciding with peak gastrointestinal symptoms ( A key strength of this study lies in its conduct within a publicly funded healthcare system, entirely independent of pharmaceutical industry sponsorship, thereby enhancing both methodological rigor and external validity
Ferrari A et al (2002) Clear cell sarcoma of tendons and aponeuroses in pediatric patients: a report from the Italian and German Soft Tissue Sarcoma Cooperative Group, Cancer 12(94):32693276
