Tony Hagen is senior managing editor for The Center for Biosimilars®.
Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.
The past year was “turbulent” for the health care industry, and sales of Coherus BioSciences' pegfilgrastim product (Udenyca) were not what the company had hoped. But as the pandemic wanes, the company anticipates a change in market dynamics that will enable the product to achieve greater market share, according to Dennis M. Lanfear, president and CEO of the Redwood City, California, company.
Udenyca launched in 2019 and has achieved a roughly 20% share of the pegfilgrastim market, Lanfear said in a presentation at the 39th Annual JP Morgan Global Healthcare Conference. Coronavirus disease 2019 (COVID-19) gave a rival product a boost that denied Udenyca a greater share of the market it might otherwise have attained, he said. Pegfilgrastim is used to fight off infection associated with chemotherapy treatment.
The Onpro Battle
Amgen’s Neulasta Onpro on-body injector, launched in 2015, enables patients to receive pegfilgrastim injections at home, saving them from having to visit clinics battling to prevent the spread of COVID-19. By midyear 2020, Onpro had accumulated a 58% share of the pegfilgrastim market.
In his presentation at this year's virtual J.P. Morgan Health Care Care Conference, Lanfear predicted that vaccinations will enable patients to return to clinics for vaccinations and use of the Onpro will diminish, creating market opportunity for Udenyca.
The chief value of Onpro is its convenience for home use, although a recent study recorded failure rates from 1.7% to 6.9%. “We expect that as COVID-19 wanes, market gains at the expense of [the] Onpro share are expected to resume,” Lanfear said.
From its launch in January 2019 until September 30, 2020, Udenyca has achieved $720 million in revenues, Lanfear said. There are now 4 pegfilgrastim biosimilars on the market; most recently, Pfizer’s Nyvepria was launched in December 2020. Amgen’s originator pegfilgrastim products, including Onpro, control about 70% of the market. Although Lanfear predicted that Udenyca’s sales growth curve would point upward more sharply in 2021, he acknowledged the market power of the on-body injector and indicated that Coherus is working on its own version. He said it would be premature to share an anticipated market entry date.
In a discussion of the company’s biosimilar pipeline of products, Lanfear noted the company is developing versions of ranibizumab and aflibercept, both of which are for treatment of macular degeneration. Their respective originator brands are Lucentis and Eylea. The markets for each of these products are about $3 billion, Lanfear said.
Coherus is also developing a biosimilar to adalimumab (reference, Humira), which he said would likely enter the market in December 2023. The biologic is for treatment of rheumatologic and gastrointestinal disorders. Coherus submitted its biologics license application for FDA approval of its adalimumab biosimilar candidate (CHS-1420) at the end of 2020, and assuming regulatory approval, a launch is planned on or after July 1, 2023.
The adalimumab market is changing, with providers starting to use citrate-free, high-concentration versions of this product, which may complicate marketing plans for Coherus and other biosimilar producers.
According to Lanfear, Humira achieved US sales of $15.9 billion in 2020. AbbVie, the originator company, has employed its exclusivity advantage to impose a steady stream of adalimumab price hikes. Humira prices have climbed 6-fold since 2005, according to Lanfear’s presentation.
“Relentless Humira price hikes and payer expense burden create a pent-up demand for biosimilar alternatives,” he said, predicting a “massive decoupling” ahead that would shift supply contracts to biosimilar manufacturers, once biosimilar versions of adalimumab become available in the United States, in 2023.
In a description of Coherus’ marketing strategy for leveraging greater biosimilar revenues, Lanfear said Coherus would target payers most of all, because they have the greatest control over what biologics are used by the health care community, relative to specialty pharmacies, providers, and patients. “We expect payers to have a significant share of power in selecting products and to drive share away from originators if properly incentivized.”
Coherus also has a bevacizumab biosimilar candidate (reference, Avastin) that it is developing in partnership with Innovent Biologics to submit for regulatory approval in the second half of 2021, Lanfear said. Bevacizumab is for the treatment of various types of cancer, including colorectal, lung, and kidney.