Novartis Confirms It Has Launched Biosimilar Pegfilgrastim, Ziextenzo, in the United States

Novartis has confirmed in an email to The Center for Biosimilars^® that it has launched Sandoz’s pegfilgrastim biosimilar, Ziextenzo, in the United States. According to Novartis, the wholesale acquisition cost (WAC) for Ziextenzo is $3925, or an approximate 37% discount off the WAC for the reference product, Amgen’s Neulasta.

The discount for Ziextenzo is deeper than those initially offered for competitor biosimilars; when Coherus BioSciences launched its biosimilar, Udenyca, in the US market in January of this year, it did so at a list price of $4175 per unit, or a 33% discount. That price matched that of Mylan and Biocon’s Fulphila, which launched in July of 2018.

It remains to be seen how much of an impact the additional discount will make for the new biosimilar contender. In May of this year, UnitedHealthcare indicated in a network bulletin that it will prefer the brand-name pegfilgrastim over biosimilar options. In that bulletin, UnitedHealthcare said that the use of Neulasta Onpro (a presentation of the pegfilgrastim product in an on-body injector device) or Neulasta in a vial would be required before use of one of the then-available biosimilars would be allowed.

The biosimilar was approved by the FDA on November 5, after Sandoz submitted data from a pivotal pharmacokinetic (PK) and pharmacodynamic study.

The study was a single-dose, 3-period crossover study that compared the biosimilar with the US-sourced and EU-sourced reference pegfilgrastim, and it compared the US and EU references. The study sought to address the high intersubject variability (ISV) linked to target-mediated clearance with pegfilgrastim; the 3-way crossover design was intended to address ISV and to provide a bridge between the EU and US reference pegfilgrastim products.

A previous PK study was conducted in healthy volunteers, and the biosimilar has also been studied in phase 3 clinical trials (PROTECT-1 and PROTECT-2) in patients undergoing chemotherapy.

The biosimilar is also approved in the European Union, where it was authorized in January of this year.