Novartis gains US approval for biosimilar Ziextenzo referencing Amgen's Neulasta

Novartis' Sandoz unit announced Tuesday that the FDA has approved Ziextenzo (pegfilgrastim-bmez), a biosimilar version of Amgen's Neulasta (pegfilgrastim), and that it plans to launch the therapy in the US "as soon as possible this year." Ziextenzo, which was cleared in Europe in 2018, is indicated to decrease the incidence of febrile neutropaenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Novartis noted that with this latest approval of Ziextenzo, Sandoz is the only company to offer US physicians long- and short-acting filgrastim biosimilar treatment options.

The decision was based in part on data from a study, dubbed LA-EP06-104, that compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim. According to Novartis, pharmacokinetic and pharmacodynamic similarities were demonstrated in all three comparisons, with no clinically meaningful differences observed in terms of safety or immunogenicity among the treatment groups.

Sandoz president Carol Lynch said the approval "expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option." She added that it also builds on "the foundation...we developed with our short-acting filgrastim Zarxio (filgrastim-sndz), the leading filgrastim by market share in the US, including consistent product supply and reliable patient services."

Novartis resubmitted its Ziextenzo filing earlier this year, with the inclusion of data from the LA-EP06-104 study, after having received a complete response letter from the FDA in 2016. The rejection allowed Coherus BioSciences and Mylan to beat Novartis to the US market with their respective Neulasta biosimilars, Udenyca (pegfilgrastim-cbqv) and Fulphila (pegfilgrastim-jmdb). For related analysis, see ViewPoints: Analysts debate Coherus' biosimilar bite out of Neulasta.

Meanwhile, Amgen recently reported that Neulasta generated sales of $711 million in the third quarter, down 32% from the year-ago period, in part as a result of biosimilar competition.


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