- Novartis' Sandoz unit on Tuesday received Food and Drug Administration approval to launch its Neulasta biosimilar, Ziextenzo, which the Switzerland-based company said should take place before the end of 2019.
- Ziextenzo will join Mylan's Fulphila and Coherus BioSciences' Udenyca in competing with Amgen's original product, which treats infection in cancer patients undergoing chemotherapy by stimulating white blood cell production.
- Fulphila and Udenyca, which the FDA approved last year, have taken a combined 22% market share as of August and have helped drive Neulasta prices down, according to Bernstein analyst Ronny Gal.
Amgen knew biosimilars were coming for its second-biggest seller. The launch of the Onpro device four years ago, which allows for in-home injection, as well as an exclusive contract with the biggest U.S. private health payer in United Healthcare were efforts to defend against biosimilar competition when the final Neulasta (pegfilgrastim) patents expired in 2015.
Biosimilars' market share in the U.S. has not grown as quickly as in Europe, where three competitors including Sandoz now comprise 37%, according to Gal. However, Cowen & Co. analyst Ken Cacciatore, who covers Coherus, believes the relatively small U.S. biosimilar uptake and the price discount for biosimilars should provide opportunity for "for both Coherus to grow while Sandoz garners its own share."
Ziextenzo might have been launched in the U.S. earlier if not for a Complete Response Letter it received in 2016.
In an Oct. 25 note to clients, Gal wrote that Neulasta average sales price as of August had dropped 6% since biosimilar introduction, to about $4,100 a vial. Udenyca costs 6% less than Neulasta, and Fulphila 11%. Patients take one vial per chemotherapy cycle and two for every exposure to immune-suppressive levels of radiotherapy.
In 2017, Medicare Part B, which pays for drugs administered in healthcare facilities, spent about $15,000 on average for every patient who took Neulasta.
Neulasta accounted for $4.5 billion in total sales for Amgen in 2018, the first year it faced price competition.
For Novartis, Ziextenzo is the eight biosimilar it has launched but only its second in the U.S. after Zarxio, its Neupogen rival.
Its lookalike to Amgen's Enbrel (etanercept), called Erelzi, has been delayed by court decisions that have upheld Amgen's patents, while its Humira (adalimumab) competitor, called Hyrimoz, will need to wait until 2023, per a settlement with AbbVie.
Correction: A previous version of this story incorrectly stated the number of biosimilars Novartis has launched.