- Coherus BioSciences this week announced its biosimilar of Amgen's Neulasta, Udenyca, will be priced at $4,175 per unit, a 33% discount on Neulasta's list price of $6,231, and below the originator's average selling price of $4,422.
- Udenyca is now approved in both the U.S. and the European market. At a price of $4,175, Udenyca will match the list price set by Mylan and Biocon's rival Neulasta biosimilar Fulphila, which launched earlier this year.
- Udenyca's Medicare billing code should be available on Jan. 1, with the drug launch expected Jan. 3, backed up by launch campaigns and an "abundant market supply capacity," according to the company.
Amgen is encountering the pressures of biosimilar competition.
In the third quarter of 2018, Neulasta (pegfilgrastim) sales fell 6% year over year. Epogen (epoetin alfa) also lost sales to biosimilars, falling 5% from a year ago. Amgen top-seller Enbrel (etanercept) also faces a biosimilar threat, although the company is currently litigating a challenge from Novartis' Sandoz.
Together, these three drugs made up about half of Amgen's total product sales in 2017.
The approval of Coherus BioSciences' Udenyca (pegfilgrastim-cbqv) by the European Comission (EC) in September and the Food and Drug Administration in November makes it the second biosimilar to Amgen's Neulasta to get a yes in both markets.
Mylan and Biocon's Fulphila (pegfilgrastim-jmdb) beat Udenyca to a U.S. approval, and has secured an OK by the European Medicines Agency (although not yet a market authorization by the EC).
Udenyca's price, one-third below the biologic, will attempt to capture market share from Amgen.
"Beyond list price, we also have contracting plans that we believe will deliver additional value to payers, providers and patients in the long term, facilitating uptake and market conversion," said Coherus CEO Denny Lanfear on the third quarter earnings call.
Coherus is readying itself for launch. All of its production sites have completed FDA inspections, and its production networks have a "consistently positive inspection record" with the U.S. and EU regulators, according to the company.
Chris Thompson, Coherus' senior vice president for sales, has emphasized that the launch and promotional strategy for biosimilars will mirror a branded biologic launch more than that of a generic.
Ken Cacciatore, an analyst at Cowen, believes Udenyca could capture 10% market share or more in the near term, with the potential to reach toward 30%.
"Udenyca could be a nicely durable $250 million+ near-term product, with hopes that it could escalate to $350-400 million over the next few years," he wrote in a note to investors.