The following has been posted with the permission of their authors James E. Valentine and James C. Shehan of Hyman, Phelps & McNamara as part of their FDA Law Blog.
August 09, 2014
FDA’s New Biosimilars Guidance Has Sponsors Provide Information to Win Reference Product Exclusivity; Liberal Criteria Opens the Door to More Exclusivities Being Awarded
By James E. Valentine* & James C. Shehan —
On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors of BLAs past, present, and future, on notice that FDA wants them to submit certain information for their biologics to be considered for “reference product exclusivity.” But that’s a burden that sponsors will likely gladly bear, because FDA’s proposed broad interpretation of structural modification, a key term in determining whether a related product differs enough from a sponsor’s structurally related product to merit its own exclusivity, makes more products eligible for exclusivity than is required under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”).