Population Pharmacokinetics (PopPK) in Biosimilar Studies:

This white paper by Somru BioScience discusses the purpose, challenges, solutions, and a case study related to Population Pharmacokinetics (PopPK) modeling in biosimilar studies.
Key points include:
Purpose of PopPK: It assesses similarity between biosimilars and reference products, supports indication extrapolation, optimizes study design, and helps handle complex kinetics, especially for therapeutic proteins.
Challenges: These include inter-individual and immunogenicity variability (anti-drug antibodies), sparse data in Phase III studies, covariate imbalance, and difficulties in model selection and validation.