Biosimilar company Coherus BioSciences (CHRS 15.05, -5.60 -27.1%) slips to nearly one-year lows today in reaction to a complete response letter issued by the U.S. Food and Drug Administration for its biologics license application for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, under the 351(k) pathway. The company’s CHS-1701 candidate displayed positive results and met all co-primary endpoints back in July of 2016. With safety profiles similar to Amgen’s (AMGN) Neulasta, all signs were good until the spring of this year.
Most recently, CHRS on April 25 announced the completion of the initial phases of the Biologics Price Competition and Innovation Act (BPCIA) patent exchange procedure for its Neulasta (pegfilgrastim) biosimilar candidate, CHS-1701.
Then, about a month ago when CHRS announced its Q1 results, the company announced the anticipation of the commercial launch of CHS-1701 in the mid-second half of 2017 depending on Supreme Court decision on 180-day notice of commercialization and other litigation matters. At that time, the company also announced the anticipated European marketing authorization in the fourth quarter of 2017 as well as the Biosimilar Use Fee Act (BSUFA) date of June 9, 2017.
Then finally today, the first business day after the aforementioned BSUFA date, the FDA’s CRL comes out. 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.
In comments on a conference call today, CHRS also noted that it was confident there should not be an Adcom for the CHS-1701 indication. Additionally, management noted the possible delay of about 13 months due to the CRL as the company sees spending about 30 days to get a Type 1 meeting scheduled with the FDA, about six months to respond to the FDA requests notated in the CRL, with up to six months to re-evaluate the resubmission.