Thoughts on FDA’s final clinical pharmacology guidance on biosimilars and the draft guidance on interchangeable biologics.
By Peijuan (Penny) Zhu, Ph.D., Sandoz Inc.; Shrinivas Savale, Ph.D., independent consultant; and Gillian Woollett, M.A., D.Phil., Avalere Health
Clinical pharmacology studies are critical in demonstrating biosimilarity because they provide clinical pharmacokinetic/pharmacodynamic (PK/PD) similarity data to confirm biosimilarity. These studies address residual uncertainties after the analytical evaluation, add to the totality of evidence supporting biosimilarity, and guide the need for any subsequent clinical testing. In some cases, clinical pharmacology studies alone can be sufficient to address whether there are clinically meaningful differences between products.