Biosimilars Breaching Borders: How FDA and EMA Find Common Ground
By HA Dowlat and Karl-Ludwig Rost
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 European perspective of biosimilar development with a
focus on PK/PD, which helps provide context to an interpretation of the three new
draft guidances from the US Food and Drug Administration (FDA) published in February
2012: Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity
to a Reference Product, Guidance for Industry Quality Considerations in Demonstrating
Biosimilarity to a Reference Protein Product and Guidance for Industry Biosimilars:
Questions and Answers Regarding Implementation of the Biologics Price Competition and
Innovation Act of 2009
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