- Coherus BioSciences is having more success selling its biosimilar version of Amgen's Neulasta than Wall Street expected, announcing Friday preliminary estimates of between $36 to $38 million in net sales of the copycat biologic during the first three months of 2019.
- While dwarfed by Neulasta's roughly $1 billion in quarterly sales, those figures are about seven times higher than what analysts had predicted Coherus would earn from the first quarter of sales from its copycat version, called Udenyca.
- Udenyca is the second biosimilar version of Neulasta to launch in the U.S., debuting Jan. 3 with a list price 33% lower than Amgen's drug. Another biosimilar, developed by Mylan, became available to patients last year.
The commercial struggles of biosimilars in the U.S. are well documented at this point.
Of the 18 approved by the Food and Drug Administration, only seven are commercially available. Sales to date of those already launched are relatively meager, hamstrung by contracting hurdles and lingering cautiousness from physicians.
U.S. sales of Pfizer's Inflectra (infliximab-dyyb), for example, totaled only $70 million in 2018, the Remicade (infliximab) biosimilar's second full year on the market. Pfizer has sued Johnson & Johnson for anticompetitive practices related to Remicade.
Analysts see biosimilar competition to Neulasta more optimistically, however.
In a recent note to clients, for example, Bernstein's Ronny Gal noted a better start for Neulasta biosimilars, with few blocks on the drug from payers.
Coherus' preliminary sales estimate for the first quarter seem to confirm that view. Coherus will disclose fuller details on the launch when it holds its May 9 quarterly earnings call.
Ken Cacciatore, an analyst at Cowen, wrote in an April 7 investor note that the Coherus numbers suggest Udenyca (pegfilgrastim-cbqv) could capture as much as a 10% share of the $4 billion Neulasta market by year's end.
More competition to Neulasta could soon be arriving, however. Novartis' Sandoz unit recently resubmitted its biosimilar version of the drug, nearly three years after the FDA had knocked back its first attempt to win approval.
Amgen's defense has centered on switching Neulasta patients from the standard pre-filled syringe to an on-body injector that allows for at-home dosing.
Called OnPro, the on-body injector form accounted for roughly three-fifths of the U.S. market for Neulasta, according to January 2019 data cited by Bernstein's Gal.
Shares in Coherus rose by as much as 25% Monday morning on the news, before falling back to trade up 12% by midday.