Update on Insulin Prices and Pipeline Products
March 1, 2023FDA Adds Quinacrine Hydrochloride (quinacrine) to the List of BulkDrug Substances that May Be Used in Compounding by OutsourcingFacilities (503B Bulks List)
March 1, 2023FDA has been conducting applied research on pharmacodynamic (PD) biomarkers to help facilitate biosimilar product development. This research includes clinical pharmacology studies in which participants receive varying doses of a biologic and investigators determine the biomarkers’ response. A relationship between the dose and biomarker response may indicate that the biomarker is a candidate for a PD similarity study.
FDA and outside researchers have worked to identify and evaluate biomarkers in placebo-controlled studies using advanced technologies and simulations. Some of these studies were published in the January 2023 issue of Clinical Pharmacology and Therapeutics and described in this Spotlight on CDER Science, Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development.