On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv) biosimilar product. President, CEO and Chairman Denny Lefler told financial analysts on the call that Udenyca™ will be available for patients in the U.S. beginning on January 3, 2019 at a list price of “$4,175, which represents a discount of 33% over Neulasta’s list price and is also below Neulasta’s current average selling price of $4,422.” He added that, “[b]eyond list price, we also have contracting plans that we believe will deliver additional value to payers, providers and patients in the long term, facilitating uptake and market conversion.” According to Mr. Lefler, Coherus “believe[s] this price will deliver long term economic benefit to patients and savings to the health care system,” and “also reflects long term value that Udenyca is poised to deliver in terms of quality of services in oncology marketplace, including to patients.”
With regard to the launch date, Mr. Lefler described January 3, 2019 as “the best date for our product launch for a few reasons,” including: (a) based on the time needed for “completing packaging and labeling for our final product, which is now well underway”; (b) that Coherus’ “Medicare acute code [for this product] is expected to be available on January 1st,” which Coherus views as “a key requirement to support seamless reimbursement to our Medicare patients, which constitute about 50% of the market”; and (c) that “commercial payer formularies typically reset in January, which will allow us to align their decision timing with our launch, allowing us to synchronize timing with these essential market entities.”
Vince Anicetti, Coherus’ Chief Operating Officer, elaborated on Coherus’ preparations for launch. Mr. Anicetti stated that in the past few months, during the FDA review period, Coherus had “received and successfully completed two additional FDA inspections at our production and testing sites.” He also explained that Coherus began its product label and packaging operations soon after receiving FDA approval, and that the first batch of commercial product is set to “arrive at the main distribution site later this month, and will be available for [Coherus’] January 3, 2019 launch.”
Udenyca™ remains the subject of a pending patent litigation under the BPCIA between Coherus and Amgen. Earlier this year, Coherus successfully persuaded the district court to dismiss Amgen’s lawsuit, which, as we reported today, remains pending on appeal before the Federal Circuit.