Coherus' copycat version of Amgen’s blockbuster drug Neulasta (pegfilgrastim) has been rejected by the FDA.
The biosimilar, CHS-1701, one of the company's leading pipeline lights, was seeking a marketing app that dovetailed with the license for Amgen’s original med, a long-acting granulocyte colony stimulating factor, which is used to bolster white cells in patients undergoing chemotherapy for cancer. The drug is one of Amgen's top-selling products, with around $5 billion in sales and much of that revenue stream coming from the U.S.
But today Coherus was slapped with a complete response letter from the U.S. regulator, which it says is “primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information.” It added that the FDA “did not request a clinical study to be performed in oncology patients,” which would have been a costlier delay.
It also said that the CRL “does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors.”
But the news was a major setback for the company, and its shares dropped 34% premarket.
“Coherus will work with the FDA to address the information requests,” it said in an update.
“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,” Denny Lanfear, president and CEO of Coherus, explained.
“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.”
One year ago this week, Swiss major Novartis was given the same news, saying quietly in a Q2 update that: “Sandoz [its generics and biosim unit] received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta). We are working with the agency to address remaining questions.”