Coherus just became the second biosim maker to target Amgen's blockbuster Neulasta, heating up the market rivalry not only with the biotech giant but also with Mylan and its first-to-market entrant Fulphila. The new copycat, Udenyca, doesn't have a price tag yet, but analysts figure Coherus won't be shy about allowing discounts.
The company snagged its FDA nod for Udenyca to treat cancer patients receiving myelosuppressive chemotherapy. The drug helps boost white blood cell count to help patients fight off infection.
Coherus didn’t detail its pricing or launch strategy, but the company said executives will discuss the plans during a conference call on Thursday. Mylan already has a marketed Neulasta biosimilar in Fulphila, launched this summer at a 33% discount to the brand.
And as Coherus CEO Denny Lanfear suggested in a statement, the company won't be shy about allowing discounts. Neulasta’s list price has nearly quadrupled since its 2002 approval, Lanfear pointed out. The Amgen drug generated $3.9 billion in U.S. sales last year.
“We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched,” Lanfear said.
Coherus has “in-depth understanding” of the market that will allow it to “deliver significant value to patients, payers, and providers in the U.S., including 340B hospitals, small clinics and small hospitals," Lanfear said. The 340B program mandates discounts for hospitals that serve low-income areas.
In a note, Leerink Partners analyst Geoffrey Porges wrote that Udenyca could be “at least as competitive as Fulphila in the pegfilgrastim category and is likely to put further pressure on a weakening Neulasta revenue outlook.”
Coherus has said it has plenty of supply and capacity, and a 70-person sales team is in place to bolster the rollout, according to the analyst.
Udenyca's U.S. approval follows an EU nod back in September.
Amgen is among the drugmakers facing biosim threats to pharma's top biologics; its Neupogen became the first drug to face U.S. biosimilar competition when Novartis’ Sandoz launched Zarxio in September 2015. Amgen itself makes biosimilars, and it boasts FDA approvals for Amjetiva and Mvasi, biosims to AbbVie’s Humira and Roche’s Avastin. Neither drug is for sale yet in the U.S., however, as patent flights and legal settlements have staved off the competition. In the U.S., Amgen will have to wait until 2023 to launch Amjetiva due to a patent settlement with AbbVie.
Meanwhile, as Neulasta will soon have to battle against two U.S.-approved biosims, Sandoz and Apotex also have candidates aiming for approvals.