FDA finalizes guidance on Orphan mAb sameness

FDA published final guidance on how the agency determines the sameness of mAbs under the Orphan Drug Act. The final guidance now explicitly states that FDA "does not intend to apply the considerations discussed in this guidance to determinations under the [Biologics Price Competition and Innovation] Act."

The final guidance is intended for determining sameness of mAbs only under the Orphan Drug Act, under which drugs with Orphan Drug status have an additional seven years of market exclusivity during which FDA cannot approve a sponsor's application for the same drug for the same indication. The agency determines sameness by comparing the principal molecular structures. ...