At the J.P. Morgan Healthcare Conference, Coherus Outlines "Branded Approach" to Biosimilars

During the second day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10 in San Francisco, California, Dennis M. Lanfear, president and CEO of Coherus BioSciences, presented an overview of what he called his company’s “branded approach” to selling its newly launched biosimilar pegfilgrastim, Udenyca.

First, said Lanfear, to help support the January 3 launch of the biosimilar, the company has entered into a $75 million secured credit agreement with Healthcare Royalty Partners. This infusion of capital, he said, strengthens the company’s balance sheet, but Coherus will continue to take the “firm hand” with its cashflow that it first employed when the pegfilgrastim biosimilar was subject to a Complete Response Letter in 2017 (prior to eventual approval in 2018).

The newly raised funds will help Coherus in its ambitious launch program for Udenyca, which Lanfear emphasized is not similar to a generic launch. “Our approach is that of a branded launch…this has never been done before with a biosimilar,” he said, and revealed an image of Udenyca’s tagline, “The neu thing,” a reference to the brand-name pegfilgrastim, Neulasta, that he said has been well received by the biosimilar’s customer base.

Crucial to Coherus’ strategy is its substantial discount to its reference. Lanfear explained that Amgen’s wholesale acquisition cost (WAC) for Neulasta is $6231, but its average sales price (ASP) is $4422. Udenyca’s WAC of $4175 was an attempt to “avoid the errors of other biosimilar launches who came out with a WAC that was higher than the ASP of the originator” because payers have proven to be unwilling to pay more for a biosimilar. “Our team has focused on all the biosimilar launches previously and what has gone sideways with those” to avoid repeating such mistakes, he said.

The company’s approach, he explained, focuses on payers, integrated delivery networks, and group purchasing organizations that consolidate purchasing for clinics and hospitals, as well as provider segments comprising community oncology clinics, 340B hospitals, and non-340B hospitals.

“Out of the gate, you have to have the payers lined up,” said Lanfear, noting that the company had “inked a deal last week” with Anthem. He also noted that Aetna now requires all patients to start with either Udenyca or Mylan and Biocon’s pegfilgrastim biosimilar, Fulphila, before stepping through to the higher-cost originator. “It’s not something we asked them to do, but we’re pleased to see it.”

Among provider segments, Lanfear said, cost recovery is expected to drive the market for the biosimilar, “particularly in some of the hospital segments…which are underwater and lose when they inject Neulasta.” With non-340B hospitals in mind, he said, for biosimilars with pass-through status, which Udenyca is expected to have by April of this year, reimbursement will be the biosimilar’s ASP plus 6% of the reference product’s ASP for at least 2 years, providing a significant competitive opportunity.

Looking to the future and the remainder of its biosimilar pipeline, Coherus will continue to use what Lanfear called an innovative approach to development of its products. He noted the fact that Udenyca was the first biosimilar to receive FDA approval without data from a phase 3 confirmatory trial, and he said that the company was exerting a great deal of effort on its ranibizumab and aflibercept molecules in the preclinical stage.