Pfenex applauds Senators Patrick Leahy (D-VT), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) for their efforts introducing the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act). The Act supports access to reference product for biosimilar development, thereby expediting patient access to valuable medicines.
Biosimilar developers must obtain samples of the reference product in order to conduct the necessary scientific tests to gain U.S. Food and Drug Administration (FDA) approval. Branded drug manufacturers often enact barriers to biosimilar developer access to reference product, such as by refusing to sell product to them, or impeding participation in FDA-required safety protocols. The CREATES Act would prevent such transgressions by authorizing a judge to award damages for preventing access to a reference product, and it would allow court-supervised negotiations between branded drug companies and biosimilar developers.
We look forward to lawmaker discussion around this important legislation as an important step toward expanding patient access to life-changing medications.