The Biologics Price Competition and Innovation (BPCI) Act of 2009 created a licensure pathway for biological products to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. The U.S Food and Drug Administration recently released its draft guidance for implementing the BPCI with the intention of assisting sponsors in demonstrating that a proposed therapeutic protein is biosimilar to a reference product for the purposes of a 351(k) marketing application.

Highlights from the draft guidance include the lack of a set exclusivity period, the potential for biosuperior development, and the creation of a biosimilar product development fee. In addition to a summary of the draft guidance, we have included comparisons between the proposed biosimilar pathway, the current pathway for small molecule generics, and the biosimilar guidance currently under review in the EU.

For the full report, please download the PDF version at the top of this page.

For our disclosures, please read the BioMedTracker Research Standards.