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Janssen Pharmaceutical Companies of Johnson & Johnson Submit Citizen Petition to the U.S. FDA Regarding Naming of Biosimilars
Date:1/8/2014

WASHINGTON, Jan. 8, 2014 /PRNewswire-USNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) today submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) asking the agency to require biosimilars to bear nonproprietary 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. 

"Ensuring biosimilars bear distinguishable names is of critical importance for patient safety," said Jay P. Siegel, M.D., Chief Biotechnology Officer and Head, Scientific Strategy and Policy, Johnson & Johnson.  "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."   

As FDA continues to implement the Biologics Price Competition and Innovation Act, the question of how biosimilars will be named must be addressed.  This question is currently being evaluated and will be addressed by the World Health Organization (WHO) and health authorities around the world.  Janssen submitted its Citizen Petition to communicate the company's position that requiring distinguishable names for biosimilars is critical for the safety of patients globally.

According to the Janssen Citizen Petition, the naming of biosimilars could have important patient safety implications beyond the name itself, including pharmacovigilance, product switching and extrapolation of indications.  Patients, their physicians and regulatory authorities such as the FDA need to know precisely which biological product has been used to
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SOURCE The Janssen Pharmaceutical Companies of Johnson & Johnson
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