News Feature | January 13, 2014

J&J Petitions FDA To Regulate Naming Of Biosimilars

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By Cassandra Leger

Johnson & Johnson addressed the FDA with a petition requesting that the U.S. administration regulate the labeling of biosimilars; specifically those that bear names reminiscent of their reference product but are not indistinctly the same. According to the petition, Johnson & Johnson states that distinguished versions of the names are necessary to ensure patient safety and maintain proper pharmacovigilance.

Biosimilars, which are less expensive versions of an original drug, are commonly mistaken as generic medication. However, they differ greatly. A biosimilar is a drug produced using a biological base, while a generic drug is a chemically manufactured drug. The issue regarding the naming of biosimilars comes with the production of the product itself.

The petition, which was filed under the Janssen subsidiary of Johnson & Johnson, expresses the company’s concerns regarding the possibility of product switching and extrapolation of indications. The company expressed that a biosimilar, while it can be used as an alternative to its reference drug, may not always receive FDA approval for all of the applications its reference drug can be used for. Therefore, patients may be prescribed a biosimilar which has been allowed to share a name with a reference drug, and be used to treat a condition; of which the combination of the two has yet to be approved or have successful clinical trial results backing it as a safe treatment.                                                                                                           

Currently the FDA is regulating the compliance with the Biologics Price Competition and Innovation Act, and has been addressing concerns regarding the naming of these products - a topic that the World Health Organization is currently addressing.

Jay Siegel, J&J's Chief Biotechnology Officer, recently stated "Assigning 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."

While Johnson & Johnson perceives the apparent differences in labeling names as a protective measure for patients, their views contradict that of what Novartis and Mylan believe. Both of these companies support the idea that allowing similar names in biosimilars will limit the amount of confusion they produce in the marketplace and reduce the possibility of unnecessary brand tactics.