H.C. Wainwright initiated coverage of Coherus BioSciences (NASDAQ:CHRS) with a “buy” rating and $28 price target. The stock closed at $19.75 on August 27.
“We expect approval of UDENCYA, CHS-1701, in both the U.S. and Europe this year,” writes analyst Jason Kolbert. “Our confidence level is driven by a positive recommendation from the European Committee for Medicinal Products for Human Use in July 2018 for marketing authorization of UDENYCA, a biosimilar compound targeting febrile neutropenia,” he added.
Coherus announced that the committee also reviewed all the new immunogenicity data that were required for the U.S. re-submission, so the “EU recommendation for approval adds a measure of confidence in support of our thinking U.S. approval happens later this year,” Mr. Kolbert said.
The Biosimilar User Fee Act(BSUFA) action date is Nov. 3, 2019. CHS-1701 (Neulasta biosimilar) received a complete response letter from the FDA last year. The critical issue was related to an immunogenicity assay. Coherus responded with a type I response, which set the BSUFA date.
Mr. Kolbert said a year-end approval should position CHS-1701 as the second biosimilar in the $4-billion U.S. marketplace behind Mylan, which should be launching its product following approval in June.
