Sandoz Gets FDA Approval for Its Pegfilgrastim Biosimilar, Ziextenzo

Sandoz received its long-awaited nod to begin marketing Ziextenzo, the third pegfilgrastim biosimilar. Approved and marketed in Europe in 2018, pegfilgrastim-bmez should be available for prescription by doctors before the end of 2019, according to Sandoz.

pegfilgrastim biosimilar approved

The FDA approved indications for Ziextenzo include decreasing the incidence of infection (with febrile neutropenia) in patients with non-myeloid malignancies who are administered myelosuppressive chemotherapy.

In the company’s press release, Carol Lynch, President of Sandoz Inc., said, “The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio®.”

This marks Sandoz’s fourth biosimilar approval, following Zarxio, Erelzi® (etanercept) and Hyrimoz® (adalimumab), and second product to be marketed. Sandoz follows Mylan’s Fulphila® and Coherus Bioscience’s Udenyca® in the pegfilgrastim biosimilar race, which will put greater pressure on Amgen’s reference drug franchise to retain marketshare.

Ziextenzo had a bumpy road to US approval, first submitting a 351(k) application in 2015 and receiving a complete response letter from the FDA in 2016. (Note: all manufacturers of a pegfilgrastim biosimilar have received at least one complete response letter.) Sandoz refiled for approval in April of this year. However, the company now has the opportunity to build upon the success of Zarxio and apply its existing resources to the portfolio of short-acting and long-acting granulocyte-colony stimulating factors.

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