J&J wants FDA to force different names on biosimilars

Johnson & Johnson has petitioned for biological drugs that are similar to the originals, but not the same, to be given drug names accordingly, asking the FDA to stop manufacturers using the same non-proprietary names.

The citizen petition (http://www.jnj.com/sites/default/files/pdf/JnJ-Petition-Biosimilars-Naming-FINAL.pdf) to the FDA, says: “Ensuring that biosimilars receive nonproprietary names that are similar to, yet distinguishable from, those of their reference products and other biosimilars is critical for patient safety. Biosimilars are, scientifically and legally, similar to but not the same as their reference products.”

“Our own experience with Eprex/Erypo (epoetin alfa) has informed our views and highlights important considerations concerning the naming of biosimilars.
“These considerations include the need for reliable pharmacovigilance mechanisms for detection and investigation of postmarketing safety signals, the importance of the ability to identify precisely which product a patient has received and the risks associated with inadvertent switching between products.”
Dr Jay Siegel, chief biotechnology officer and head of scientific strategy and policy, Johnson & Johnson.



Related news:

J&J petitions FDA to require ‘similar’ names for biosimilars, biologics (Reuters).

Reference link:

Janssen Pharmaceutical companies of Johnson & Johnson submit citizen petition to the US FDA regarding naming of biosimilars (Johnson & Johnson press release).

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