Coherus Confirms That It Has Launched Its Pegfilgrastim Biosimilar, Udenyca

Coherus BioSciences has confirmed that it has launched its pegfilgrastim biosimilar, Udenyca, in the United States market.

In an email to The Center for Biosimilars^®, a representative from Coherus confirmed that the California-based biosimilar developer, in keeping with its corporate plans, began sales of the biosimilar on January 3. The company previously announced that it would launch its product at a list price of $4175 per unit, or a 33% discount to the reference pegfilgrastim, Neulasta.

The biosimilar’s list price matches that of Mylan’s Fulphila, the first pegfilgrastim biosimilar to launch in the United States. Despite the fact that Coherus has matched Mylan on list price for the pegfilgrastim product, these prices do not reflect any additional rebates or discounts that the drug makers may offer as a means to differentiate their products in the US marketplace.

Coherus also recently 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. The agreement coincided with Coherus’ receipt of a Q code from CMS and the company’s application of a transitional pass-through payment status for hospital outpatient settings.

With its first biosimilar now launched in the US market, Coherus is now looking to the future. On January 1, Darlene Horton, MD, joined the company as chief medical and regulatory affairs officer.

“We are very pleased that Dr. Horton has joined the executive team at Coherus,” said Denny Lanfear, chairman, president, and CEO of Coherus, in a statement. “She is a foremost biotechnology leader and clinician with an exceptional track record of delivering value to patients and shareholders.”

Among the biosimilar projects that will fall under Horton’s purview in the months ahead are CHS-1420, a proposed adalimumab biosimilar that has completed its phase 3 clinical study in psoriasis; CHS-0214, a proposed etanercept biosimilar that has completed phase 3 clinical studies in both psoriasis and rheumatoid arthritis; CHS-3351, a proposed ranibizumab biosimilar in preclinical development; and CHS-2020, a proposed aflibercept biosimilar in preclinical development.