Sandoz Resubmits Its Pegfilgrastim Biosimilar Application

Sandoz may be chomping at the bit to market its long-delayed pegfilgrastim biosimilar. First rejected by the Food and Drug Administration (FDA) in 2016, the manufacturer of Zarxio® (filgrastim) has completed its 351(k) biosimilar resubmission for its pegylated filgrastim agent.

The FDA’s complete response letter to Sandoz required new pharmacokinetic and pharmacodynamics data, which Sandoz has provided. According to Sandoz’s press release, “The resubmission includes new data from a pivotal pharmacokinetics (PK) and pharmacodynamics (PD) study. This was a single-dose, three-period cross-over study comparing Sandoz pegfilgrastim with US-sourced reference pegfilgrastim; Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim; and US with EU-sourced reference pegfilgrastim.” Branded Ziextenzo™, this agent was approved in Europe and launched in November 2018.

Sandoz was hoping that its pegfilgrastim biosimilar would be first to market before its 2016 set back. Several other prospective pegfilgrastim biosimilar makers also received rejections from the FDA, including Mylan/Biocon’s Fulphila® and Coherus Biosciences’ Udenyca®, both of which are now marketed. If approved, Sandoz would be (at best) third to market. However, of the competitors, Sandoz is the only manufacturer that can boast both a filgrastim and pegfilgrastim biosimilar. Of course, Amgen produces both Neupogen® and Neulasta®, the respective reference products.

A FDA decision date has not yet been announced; a decision in the late third quarter of 2019 would be a reasonable expectation.

Besides Zarxio, Sandoz already has received approval for two other biosimilars (Hyrimoz®, a biosimilar of trastuzumab, and Erelzi®, a biosimliar of etanercept, but these two have not yet been launched because of outstanding patent litigation or settlements. Despite having received approval in the EU for its biosimilar of Rituxan®, Sandoz decided not to press for US approval after receiving a complete response letter from the FDA about a year ago.

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