Coherus Provides Updates on Clinical Studies

Coherus BioSciences, Inc.

, a leading pure-play, global biosimilars company with late-stage clinical products, today provided updates on its clinical programs. -- CHS-1701 (pegfilgrastim (Neulasta(R)) biosimilar): Coherus has decided to increase the total number of healthy subjects to be enrolled in its immunogenicity study as part of its Biologics License Application (BLA) enabling clinical program, in concurrence with the U.S. Food and Drug Administration. This study has a design which allows us to adjust sample size based on a preliminary blinded look at the overall anti-drug antibody rate. This immunogenicity study is projected to complete dosing in the fourth quarter of 2015 to support submission of the 351(k) (biosimilar) license application in the first quarter of 2016, within the range of prior guidance. Coherus anticipates top-line data from its pharmacokinetic and pharmacodynamic (PK/PD) study of CHS 1701 in the third quarter of 2015. -- CHS-1420 (adalimumab (Humira(R)) biosimilar): Coherus has initiated dosing in its Phase 3 study in psoriasis. Coherus anticipates initiating the PK bioequivalence bridging study by the end of the first half of 2016 with Phase 3 drug material and file a BLA in the U.S. in the second half of 2016. These projections are consistent with previous guidance. -- CHS-0214 (etanercept (Enbrel(R)) biosimilar): Topline data for the psoriasis Phase 3 study is expected in the fourth quarter of 2015 and for the rheumatoid arthritis study in the first quarter of 2016. Coherus anticipates filing a Marketing Authorization Application (MAA) in the E.U. in 2016. These projections are consistent with previous guidance. Coherus will hold a conference call on Thursday, September 3, at 5:00 p.m. ET. Conference Call Information Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international) Conference ID: 31690561 Webcast: http://investors.coherus.com Please join the conference call at least 10 minutes early to register. The webcast of the conference call will be available for replay through September 16, 2015.