Clinical Pharmacology – Biomolecular
2019 PharmSci 360
The speaker will provide updates on the current state of biosimilar programs and the FDA's Biosimilar Action Plan, including a refresher on the regulatory and scientific considerations for biosimilar development. As clinical pharmacology data play a very important role in support of demonstrating biosimilarity, a major focus of the presentation is an in-depth discussion on how to design a clinical pharmacology program with considerations at the program level and the study level, including the selection of biomarker(s) for pharmacodynamic similarity assessment . In biosimilar programs, the bioanalysis for pharmacokinetic measurements is complicated by the comparative nature of PK studies. To this end, the presentation will provide the current perspective of some best practice considerations for bioanalysis used to support biosimilar development programs in addition to sharing available resources and tools provided by the FDA.