Blog Big Molecule Watch August 23, 2022

FDA Workshop on Sept. 19, 2022: Increasing the Efficiency of Biosimilar Development Programs

The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.”  The workshop will focus on comparative clinical studies and “discuss possible innovative ideas to improve the efficiency of biosimilar development.”  The workshop will include detailed discussion on the statistical methods for these studies, e.g., the Bayesian integration of various data sources to inform the design of the comparative clinical study.  Additional discussions will focus on other clinical study design elements and recommendations to help increase the efficiency of these studies, such as the selection of endpoints.  The workshop is open to the public, but registration is required.  Further information, including how to register, is provided on the FDA site.

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