How to Build a Strong Strategy for Developing Biosimilars and Approach Bioequivalence Efficiently
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How to Build a Strong Strategy for Developing Biosimilars and Approach Bioequivalence Efficiently
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Richard Peck, Director for Regulatory Affairs at Finox, sums up the main challenges in developing biosimilars, including cost-cutting pressures and the need to take on board regulatory changes and technology shifts. The interview drills down on regulatory authority requirements for the demonstration of bioequivalence and how this can prove an obstacle to developing biosimilars. Exploring the other side of the coin, the interview takes a look at the key opportunities available today in developing...
Tags:
biosimilars
biosimilar development
follow-on biologics
bioequivalence
regulatory authority requirements
regulatory affairs
bioavailability
bioequivalence and bioavailability
Richard Peck
