Democratic and Republican senators have echoed their House colleagues in a letter to the Food and Drug Administration (FDA), indicating that Congress intended, in enacting the Biologics Price Competition and Innovation Act, that the exclusivity to be accorded innovations under its terms refers to data exclusivity and not market exclusivity for innovator products. Information about the House letter appears in Issue 5 of this Bulletin.
In their January 7, 2011, letter, Senators Kay Hagan (D-N.C.), Orrin Hatch (R-Utah), Michael Enzi (R-Wyo.), and John Kerry (D-Mass.) noted that the data exclusivity provision “prohibits FDA from allowing another manufacturer of a highly similar biologic to rely on the Agency’s prior findings of safety, purity and potency for the innovator product, for a limited period of time.” The senators agreed with the House members that a biosimilar manufacturer is not prohibited from “developing its own data to justify FDA approval of a full biologics license application rather than an abbreviated application that relies on the prior approval of a reference product.”