Back to: FDA Generic Drugs Forum 2025
Presenter
Juhyun Kim, PhD
Senior Pharmacologist
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
United States Food and Drug Administration (FDA)
Dr. Juhyun Kim serves as a bioequivalence assessor in DBIII, OB, OGD. She reviews bioequivalence studies of various dosage forms of generic drugs (e.g., ANDAs, Controlled Correspondences, protocol etc.). Currently, she serves as a subject matter expert lead for pharmacokinetics in DBIII and topical subject matter expert. Prior to joining OGD in 2014, she worked in the pharmaceutical industry as drug metabolism and pharmacokinetic specialist for 7 years and also taught graduate student as an adjunct professor. She received her PhD in pharmaceutics from The Ohio State University.
Abstract
At the 2025 Generic Drugs Forum, Juhyun Kim from the Division of Bioequivalence III presents on common bioequivalence (BE) deficiencies in abbreviated new drug applications (ANDAs) for extended-release (ER) tablet formulations. Drawing from 157 ANDAs submitted through 2024, Kim identifies 224 first-cycle BE deficiencies—primarily in dissolution testing, bioanalysis, pharmacokinetics, and formulation. She highlights that 37% of deficiencies relate to dissolution, with issues such as inadequate multi-pH media data and compromised quality control methods. A case study on Metoprolol Succinate ER tablets illustrates how differences in formulation design between reference and test products can impact BE outcomes—especially in split tablet testing. Kim emphasizes the importance of understanding reference product design and adhering to regulatory guidance to avoid deficiencies. She concludes with strategic recommendations for improving submission quality and reducing review times, noting that first-cycle adequacy rates have significantly improved under successive GDUFA programs.