On June 12, 2017 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported that the U.S. Food and Drug Administration ("FDA") has issued a complete response letter ("CRL") for its biologics license application ("BLA") for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway (Press release, Coherus Biosciences, JUN 12, 2017, View Source/news-releases/news-release-details/coherus-biosciences-receives-complete-response-letter-fda-its" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-receives-complete-response-letter-fda-its" rel="nofollow">View Source [SID1234531703]).
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The CRL 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. The FDA did not request a clinical study to be performed in oncology patients. Additionally, 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.
Coherus will work with the FDA to address the information requests.
"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 Denny Lanfear, President and CEO of Coherus BioSciences. "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."
Coherus’ management team will host a conference call on Monday, June 12 at 8:00 a.m. EDT.
Conference Call Information
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID: 35568643
Please join the conference call at least 10 minutes early to register.
A replay of this conference call will be posted to the company’s website View Source and will be available until July 12, 2017.