Insights: Publications Biologics Price Competition & Innovation Act (BPCIA): Litigation Considerations

Thomson Reuters, Practical Law | Practice Note

A Practice Note discussing strategic considerations when litigating a biosimilars case under the Biologics Price Competition & Innovation Act (BPCIA). It explains biologics, discusses the history and intent behind the BPCIA, the Food & Drug Administration’s (FDA)’s Purple Book, biosimilar FDA regulatory approval and exclusivities, strategic pre-litigation and litigation considerations for both reference product sponsors and biosimilar applicants, and antitrust considerations in BPCIA settlements.
close
Loading...
If you would like to receive related insights and information from Kilpatrick Townsend, please provide your contact details by filling out the form and clicking “Agree.” If you would like to access the PDF only, please click “Download Only.”