J&J’s Janssen units file Citizen Petition with FDA on biosimilars naming

Health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Pharmaceutical companies have submitted a Citizen Petition to the US Food and Drug Administration, calling on the agency to require biosimilars to bear non-proprietary names that are similar to, but not the same as, those of their reference products or of other biosimilars.

The Petition states that distinguishable names are essential for enhancing patient safety and to ensure effective pharmacovigilance. This is in contrast to the views of those companies already developing biosimilars versions of biological drugs.

"Ensuring biosimilars bear distinguishable names is of critical importance for patient safety," said Jay Siegel, chief biotechnology officer and head of scientific strategy and policy, at Johnson & Johnson, adding: "Names that are similar but not the same will appropriately reflect the legal and scientific reality that biosimilars are similar to but not the same as their reference products or other biosimilars."