Challenges in Early Comparability Assessment of Biosimilars
Tue Mar 20, 2012
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Abstract:
The success of biologically-derived drug products has driven the demand for “biosimilar” versions of these products to increase competition and reduce costs to patients and providers. However, these products are complex to manufacture. Once an apparent source of drug substance has been established it is critical to understand whether its safety, immunogenicity, pharmacokinetics and pharmacodynamics are comparable to the innovator product before proceeding to expensive multi-center patient studies.
This webinar addressed the key elements of early biosimilar development that provide the bridge between the manufactured product and the larger clinical studies needed to prove comparable efficacy and safety.
Presentations:
J. Fred Pritchard, PhD
Vice President, Global Drug Development, Celerion
Introduction and Moderator
Raymond Farmen, PhD
Vice President, Global Bioanalytical Services, Celerion
Early Stage Studies of Biosimilars
Michael E. Placke, PhD, DABT
Senior Vice President and General Manager, Ricerca Biosciences
Preclinical Development Strategies for Assessing Biosimilar Comparability
To view this webinar: Click Here