Drugs

FDA on Pharmacodynamic Biomarker Research

FDA researchers are looking at the possibility of speeding biosimilar development through a streamlined approach in which pharmacokinetic (PK) and pharmacodynamic (PD) similarity data are submitted with comparative safety and immunogenicity data. An agency notice says investigators can collect PK and PD data from shorter, less costly studies, often enrolling healthy participants. It notes that PD similarity studies rely on PD biomarkers, biological molecules that signal a normal or abnormal process.

FDA has been conducting applied research on PD biomarkers to help facilitate biosimilar development, the notice says. The 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 says.

The notice says FDA and outside researchers have worked to identify and evaluate biomarkers in placebo-controlled studies using advanced techniques and simulations. Some of the studies were published in the January issue of Clinical Pharmacology and Therapeutics. The notice describes the studies on cholesterol medications, asthma medications, multiple sclerosis drugs, and supportive care medications for cancer.

“The FDA research … has shed new insights on analysis of PD biomarker data, increased our understanding of bioanalytical considerations when analyzing PK and PD endpoints, and demonstrated the use of novel ‘omics’ methods for identifying potential PD biomarkers for biosimilar development,” FDA concludes.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome