- Novartis' Sandoz has resubmitted an application with the Food and Drug Administration for its biosimilar of Amgen's Neulasta, hoping to be the third copycat competitor to market after its prior application was rejected in 2016.
- Nearly three years after receiving that Complete Response Letter, Sandoz added data from a pivotal pharmacokinetics study comparing the biosimilar to the reference biologic, the company stated Tuesday.
- Sandoz's version of Neulasta has already gone commercial in Europe, representing one of the company's eight marketed biosimilars in that region. The Novartis unit has three approved biosimilars in the U.S. but only one, a copy of Amgen's Neupogen, is commercially available.
Neulasta (pegfilgrastim) has been a prime target for biosimilars since the Amgen drug's last material U.S. patent expired in 2015.
First approved in the U.S. in 2002, Neulasta remains a blockbuster product for Amgen. The drug posted about $4.5 billion in sales for each of the past two years, accounting for roughly one-fifth of the company's total sales.
Last year laid the groundwork for stateside competition, with the FDA respectively approving copycats from Mylan and Coherus BioSciences in June and November.
Bernstein's Ronny Gal predicted "a very gradual conversion" to Neulasta biosimilars in a note to investors last week. Citing prescription data from Iqvia for January, Gal said the U.S. commercial push is in its early stages but off to a better start than some other biosimilars.
There is some payer support and "critically, almost none of them is blocking the biosimilar," the analyst wrote. "However, hospitals prefer the brand given reimbursement."
Amgen's strategy to preserve market share is switching patients to OnPro, a device that helps differentiate the branded biologic by allowing users to administer dosing at home rather than going into a hospital or doctor's office. Following the device's launch in 2015, its use has grown to represent a majority of Neulasta patients.
"We remain confident that our experience, established record of quality, dependable supply, and innovative solutions such as Onpro will serve us well," Murdo Gordon, Amgen's commercial head, said on the company's fourth quarter earnings call.
Despite OnPro, biosimilars are pressuring Neulasta's price. Coherus and Mylan both launched their copycats with a list price of $4,175 per unit, a 33% discount to the branded biologic and below its average selling price of $4,422.
Neulasta isn't the only older Amgen product facing competitive threats in 2019. Its top-selling drug Enbrel (etanercept) faces an imminent court ruling that could expose the biologic to competition.
And even some of its recent launches are fighting for sales in fiercely competitive markets, including its PCSK9 inhibitor Repatha (evolocumab) and CGRP inhibitor Aimovig (erenumab).
Taking all that into consideration, the big biotech predicted in January year-over-year overall sales to decline between 3% and 8%.