What are the rules today, and how can we influence what they will look like tomorrow?

A brave new world opened under the Biologics Price Competition and Innovation Act of 2009, which ushered in biosimilar products.  We help our clients understand the latest FDA pronouncements and court decisions affecting the development and approval of these exciting new products.  We also work with clients to help persuade the Agency about how it should consider regulating these products in the future.  We can help you:

  • Comment on FDA Draft Guidance and Citizen Petitions
  • File Citizen Petitions
  • Litigate Biosimilar Issues