The track-and-trace system created by the Drug Quality and Security Act will not provide biosimilars with identifiers that can substitute for unique non-proprietary names, Johnson & Johnson Chief Biotechnology Officer and Head of Scientific Strategy and Policy Jay Siegel argues.
J&J filed a citizen petition Jan. 8 asking FDA to give biosimilars non-proprietary names “that are similar to, but not the same as, those of their reference products or of other biosimilars