Characteristics of Clinical Trials Evaluating Biosimilars in the Treatment of Cancer: A Systematic Review and Meta-analysis.
Sign Up to like & getrecommendations! Published in 2022 at "JAMA oncology"
DOI: 10.1001/jamaoncol.2021.7230
Abstract: Importance Biologics account for almost half of US drug spending but may be subject to competitive pricing pressures by US Food and Drug Administration-approved biosimilars. The extent of the preapproval clinical testing that is needed… read more here.
Keywords: clinical trials; reference drug; efficacy; drug ... See more keywords
Biosimilarity Assessment of the Biosimilar Teriparatide Candidate and the Reference Drug in Healthy Subjects
Sign Up to like & getrecommendations! Published in 2023 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.1221
Abstract: SAL001, a recombinant form of parathyroid hormone, is a biosimilar drug to teriparatide and is planned to be used in osteoporosis treatment. A single‐dose, randomized, open‐label, 2‐way crossover trial was conducted in healthy subjects to… read more here.
Keywords: reference drug; reference; concentration; teriparatide ... See more keywords