Ahead of Udenyca Launch, Coherus Signs 340B Contract Agreement With Apexus

Coherus Biosciences, which recently gained its first biosimilar approval for Udenyca, a pegfilgrastim biosimilar referencing Neulasta, has announced that it has signed a 340B prime vendor program contract with Apexus LLC.

Apexus is the Health Resources and Services Administration’s designated prime vendor for the 340B Drug Pricing Program, under which it contracts with nearly all of the 340B-eligible covered entities, and the 340B channel accounts for approximately 35% of the reference pegfilgrastim units sold in the United States.

“Apexus is pleased to be one of Coherus BioSciences’ first partners in the launch of Udenyca,” said Chris Hatwig, president of Apexus, in a statement. “We look forward to working with Coherus in optimizing biosimilar use with this new agreement for Udenyca and to lowering drug pricing while improving patient access.”

Coherus also revealed that it has received a Q code from CMS for Udenyca, and that the code will be active in time for the January launch of Udenyca. With the Q code in place, it will now apply to CMS for transitional pass-through payment status for hospital outpatient settings.

“We continue to progress toward achievement of a robust UDENYCA™ launch on January 3, 2019,” said Denny Lanfear, CEO of Coherus. “The Apexus agreement and [Q code] issuance are [2] important initial components for bringing choice and significant value to patients, payors and providers across the [United States].”

Coherus’ biosimilar was approved in November, making it the second pegfilgrastim biosimilar to gain the FDA’s authorization. First approved was Mylan and Biocon’s Fulphila, which has already launched in the United States. Coherus has said that it will match Mylan’s product on price by discounting its biosimilar by 33% relative to the reference product. Both Udenyca and Fulphila will carry list prices of $4175 per unit.