More Details on Coherus Bioscience’s Udenyca Launch

Go big or go home, seems to be the message of Coherus’ President Dennis Lanfear. At the JP Morgan Investor Conference yesterday in San Francisco, he outlined what he considers a “full-on branded launch” for the biosimilar maker’s key product. Udenyca was officially launched on January 3.

In preparation for the launch of Udenyca, Coherus Bioscience secured $75 million in financing to shore up its cash position and to support its marketing effort.

Udenyca launch

The First Payer Deal for Udenyca

More than half of the current pegfilgrastim claims are reimbursed by commercial payers, with Medicare accounting for an additional one-third. Mr. Lanfear announced a couple of important payer developments that should benefit sales immediately. He said that Coherus “inked a deal with Anthem Blue Cross Blue Shield last week,” but did not elaborate on the terms. Although he alluded to a press release on Coherus’ website, none had been posted at the time of this writing. He also mentioned that Aetna and Blue Cross Blue Shield of South Carolina had independently begun “requesting Neulasta users to step through Fulphila or Udenyca before filling those claims.”

The group purchasing organization (GPO) market “is highly focused,” said Mr. Lanfear. “About a dozen players account for 95% of the market. 340B hospitals represents around $963 billion in annual revenue. Vizient accounted for $824 million in Neulasta sales last year (about 35% of the non-340B market), and welcomed us to the market.”

Targeting the Greatest Pegfilgrastim Market Opportunities

He believes, “Biosimilars with pass-through status can provide significant value in non-340B settings. They may be the lowest price side of the market, but most motivated.” According to Mr. Lanfear, these facilities’ efforts at cost recovery is expected to drive the market.

Udenyca and Fulphila are priced identically at $4,175 or at a 33% discount to Neulasta Udenyca’s 33% WAC discount per syringe to avoid payer disincentives. Specifically, after discounting and rebates, Amgen’s ASP for Neulasta was $4,422, which gives the payer an immediate ASP discount. In previous biosimilar launches, their manufacturers’ smaller discounts had actually resulted in higher ASP costs than the reference product. In those cases, payers were reluctant to encourage biosimilar use, at least until the biosimilar had sufficient time in the marketplace where its own ASP could be calculated. “Having our unique HCPCS code results in an ability to control our own ASP,” said Mr. Lanfear. This is the direct result of the current administration’s efforts to fix the original J-code rule.

Further, he believes that Coherus can take advantage of Udenyca’s reimbursement opportunity in the buy-and-bill sector. At present, Neulasta is reimbursed at ASP – 22.5%. [Non-340b] pass-through status will be designated in April 1, 2019, and Udenyca will be reimbursed at ASP + 6% for at least 2 years from that date. (Fulphila currently has pass-through status). This prevents biosimilars from being disadvantaged from the provider perspective.

A National and Regional Sales Structure

To support the new launch, Coherus has created a formidable sales force and structure, including:

  • 67 Oncology account managers
  • 7 Regional sales directors
  • 7 Key account directors
  • 7 Field reimbursement specialists
  • 7 Medical science liaisons
  • 3 Group purchasing directors
  • 4 Payer directors

Mr. Lanfear believes that creation of this extensive sales organization has not been done before with a biosimilar. And he emphasized that they expect to leverage this salesforce infrastructure for its pipeline products, including biosimilar adalimumab, biosimilar ranibizumab, biosimilar aflibercept, and a small-molecule treatment for nonalcoholic steatohepatitis (NASH).

Coherus has ramped up its production, to be able to handle demand from all its customers, and it has used the LASH Group to develop the Coherus COMPLETE support site for patients and providers.

Coherus’ plan for a “branded-type” launch for its biosimilar pegfilgrastim seems to afford benefits in pricing, sales, supply, and services. We await news of their progress.

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