In the midst of the Zarxio (filgrastim-sndz) biosimilar review, FDA inadvertently sent a CMC-related information request intended for the product’s sponsor, Sandoz Inc., to another entity.

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On Jan. 20, FDA emailed an information request intended for Sandoz to a U.S. agent not associated with the Novartis AG division. Soon thereafter, the email recipient (who is not identified in FDA review documents) notified the agency that he had received the email in error. The individual agreed to delete the email and to not retain any copies of the information or to use, distribute or disclose the contents of the email.

FDA followed up with a same-day letter requesting the individual provide the Office of New Drugs with a letter “confirming this agreement” and “indicating that he has deleted the email and any copies.”

The information request, which pertained to hold time validation protocols, was subsequently emailed to Sandoz later on Jan. 20.

In a Jan. 29 letter to Sandoz, Leah Christl, OND’s associate director for therapeutic biologics on the Therapeutic Biologics and Biosimilars Team, explained the circumstances surrounding the misdirected information request and apologized for the inadvertent disclosure of Sandoz’s information.

The Center for Drug Evaluation and Research “takes its disclosure responsibilities very seriously and we make every effort to ensure that information is disclosed only in accordance with applicable law and regulations,” Christl said.

Sorry, Wrong Email: FDA’s ‘Oops’ Moment In The Zarxio Review

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