FDA Rejects Biosimilar Naming Petitions from GPhA, Sandoz; Approves J&J’s

January 31, 2017

The FDA rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same nonproprietary names as their reference products, finding them incompatible with final guidance on the agency’s naming scheme published earlier this month.

The Generic Pharmaceutical Association and Novartis, with its subsidiary, Sandoz, had submitted separate petitions in September and October 2013, as the agency was beginning to form its policy.

They said unique nonproprietary names for biosimilar products could be detrimental to patient safety. GPhA said the use of national drug codes would be more effective for tracking and pharmacovigilance.

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