Regulatory Considerations for Biosimilars Development in the U.S.

The development of biosimilar products in the U.S. has progressed since the regulatory pathway was established as part of the Affordable Care Act. Since then, the number of active biosimilar development programs has risen steadily. The market for these products is projected to exceed 100 billion dollars by 2028. 

Listen to the full episode on Veristat’s Advancing Revolutionary Therapies Podcast to learn more about the analytical and clinical science of biosimilars and their regulatory pathway.

Learning Points

  • Biosimilars vs. Generics
  • Demonstrating biosimilarity to a reference product
  • Evaluating comparative data between a biosimilar and reference product
  • Differences between regular and interchangeable biosimilars
  • Key regulatory considerations for development of biosimilars in the U.S.
  • Financial considerations for biosimilar development



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