Shares of Coherus $CHRS tumbled 32% early Monday as news spread that the FDA has rejected its application for a biosimilar of Amgen’s Neulasta.
Neulasta earned more than $4 billion in revenue last year, making CHS-1701 a threat to one of Amgen’s oldest and biggest drug franchises. Any delay on this front could be worth big sums to Amgen, which saw shares rise about 1% early Monday. But competition is inevitable now.
The biosimilar maker rushed to reassure rattled investors that this wasn’t a program-killing event. Regulators asked for a new analysis of samples involving a revised immunogenicity assay. And the FDA also asked for more “manufacturing related process information.” There was no request for new data, which would have significantly held up a new opinion.
Even so, Evercore ISI’s Umer Raffat says the next pegfilgrastim biosimilar may have to wait for Mylan and Biocon to deliver in late 2018 or early 2019. Raffat noted that “I understand FDA is asking Coherus to use a more sensitive assay.”
This isn’t the first biosimilar to be rejected at the FDA, but these copycat biologics are becoming more common as regulators gain experience reviewing new applications.
“While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” said Coherus CEO Denny Lanfear in a statement. “We are encouraged that a patient study has not been requested and we expect that we will be able to respond to the FDA and meet with them to define a path forward in the coming months. Neulasta is the largest selling oncology biologic in the U.S., and we anticipate CHS-1701’s approval will generate significant U.S. healthcare savings while increasing patient access.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,200+ biopharma pros who read Endpoints News by email every day.Free Subscription