Tony Hagen is senior managing editor for The Center for Biosimilars®.
Sales of the pegfilgrastim oncology support biosimilar Udenyca fell off in late 2020, but Coherus doesn't see orginator company Amgen's advantage lasting much longer.
Coherus BioSciences said its pegfilgrastim biosimilar Udenyca now commands a 21% share of the overall US market for this agent and a “nearly 50%” share of the prefilled syringe segment. Company executives said they hope to begin chipping away at the market for Amgen’s Neulasta Onpro, a wearable pegfilgrastim injector kit, if the pandemic eases and conditions return to normal.
The company said it achieved Udenyca sales of $476 million for 2020 vs $359 million for 2019. In addition, Udenyca sales for the fourth quarter of 2020 were $110 million, down from $124 million in the comparable 2019 quarter. Coherus attributed the decline to COVID-19–related issues and anticipated that full-year 2021 Udenyca sales would be lower than in 2020, also because of COVID-19.
“Certainly, COVID-19 made 2020 a difficult year for Udenyca, impacting our ability to grow market share as planned in the face of new competitive entrants,” Dennis M. Lanfear, president and CEO, said during an earnings conference call.
The bottom line, said Chris Thompson, executive vice president of sales, is that Coherus must hold the line on average sales price for Udenyca to maintain a robust profit margin, although some price decline is anticipated. "The most challenging variable for us to forecast and the one over which we have the least control is, of course, price. That said, our goal is to remain disciplined, as we have been, in our long-term management of ASP while also remaining competitive. We would expect our competitors to operate in this rational manner as well."
If Conditions Return to Normal
The company is anticipating upward growth in Udenyca sales to resume in the second quarter of 2021, as conditions return to normal and the COVID-19 advantage starts to fade for Onpro, which has enabled patients to receive pegfilgrastim injections at home, sparing them the risk of infection from a trip to the clinic—although the injector kit is less reliable that clinic injections. “We expect that, as COVID-19 recedes, we will resume market share growth, largely coming at the expense of the Neulasta Onpro,” Lanfear said.
Lanfear also discussed pipeline projects to bring other biosimilars to market. He noted that the FDA has accepted the company’s biologics license application (BLA) for an adalimumab biosimilar (CHS-1420), referencing Humira and indicated for rheumatologic and gastrointestinal disorders. The FDA has set a December 2021 decision date for the BLA.
“After years of double-digit price increases with Humira, there is clearly significant pent-up demand” for a lower-cost biosimilar. There are multiple approved adalimumab biosimilars, but none of these will be available before 2023. Recently, Vizient predicted a 7.5% increase in the price of Humira before biosimilars do reach the market.
“There will be a payer-driven dynamic, and they are heavily incentivized, too, for switching from the brand to biosimilars,” Lanfear said. He added Coherus aims to achieve a 10% share of the US market for adalimumab.
Coherus is partnering with Bioeq on development of a ranibizumab biosimilar, referencing Lucentis. The drug is used for the treatment of macular degeneration. A 2021 midyear FDA application submission is planned.
The company also has a bevacizumab biosimilar in development (IBI-305), referencing Avastin and indicated for the treatment of various types of cancer. This project is in conjunction with Innovent. A pharmacokinetics study is underway.
Additionally, company executives expressed optimism for a recently announced partnership with Junshi Biosciences of Shanghai, China, to commercialize toripalimab, an anticancer PD-1 antibody, in the United States and Canada. Toripalimab is indicated for second-line treatment of unresectable or metastatic melanoma in China. Coherus agreed to pay $1.1 billion to commercialize this product and obtain options to market 2 potential other agents in the United States and Canada.