New FDA Biosimilars Guidance Makes More Drugs Eligible for Exclusivity

Aug 12, 2014

FDA Law Blog

On August 5, the FDA announced its most recent biosimilars guidance, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.” This draft guidance contains a broad interpretation of structural modification -- key in determining whether a related product differs enough from a sponsor’s structurally related product to merit exclusivity -- potentially making more products eligible for exclusivity.

The draft guidance is intended to assist sponsors developing biological products, sponsors holding Biologics License Applications (BLAs), and other interested parties in providing information that will help the FDA determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

In most scenarios, the date of "first licensure" will be the initial date the product was licensed in the U.S. However, for products that may or may not be entitled to reference product exclusivity, the FDA suggests a four-step process for sponsors to provide relevant information.

According to analysis by the FDA Law blog, while the FDA is asking sponsors to provide large amounts of complex information in this four step process in order to win exclusivity, it appears that this draft guidance provides reference product sponsors with ample opportunity to make their case that their related products are eligible for reference product exclusivity.

Read the draft guidance here