Posted by Michael Wonder on 12 Mar 2022
Biosimilar impact on oncology clinical trial design and operations
11 March 2022 - There is a wealth of data, reviews, articles, and regulatory guidance on how to conduct clinical trials to take a biosimilar from conception to market.
However, there is minimal literature describing how the addition of US FDA approved biosimilars to one or more investigational agents can affect clinical trial design and objectives.
