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    Biosimilars Breaching Borders: How FDA and EMA Find Common Ground

    Human clinical pharmacology, pharmacokinetic (PK) and pharmacodynamic (PD) studies are vital for many reasons, and uniquely useful in extrapolating the efficacy and safety of biosimilars. PK and PD studies are the most objective clinical trials, and are sensitive to changes in a drug product. But the workings and concepts behind such studies are not well understood by many in industry, and even physicians, in comparison with clinical efficacy. This article presents a E...