Coherus Finalizes CHS-1701 BLA Enabling Clinical Program and Initiates Pivotal Pharmacokinetic and Pharmacodynamic Study

Coherus BioSciences, Inc. (Nasdaq: CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced that it has finalized the Biologics License Application (BLA) enabling clinical program for CHS-1701, a pegfilgrastim biosimilar candidate, and initiated a pivotal pharmacokinetics and pharmacodynamics (PK/PD) study pursuant to feedback received from the U.S. Food and Drug Administration (FDA) on the CHS-1701 development plan. An additional immunogenicity study is planned in healthy volunteers pursuant to this BLA and is projected to be concluded in 2015 to support submission of the 351(k) (biosimilar) license application for CHS-1701 in Q4 2015 or Q1 2016.An application submitted under section 351(k) of the Public Health Service Act must contain among other things, information demonstrating that the biologic product is biosimilar to a reference product based upon the totality of data derived from analytical studies, animal studies and a clinical study or studies, all of which impact final approval.Coherus management will discuss its CHS-1701 program further on its fourth quarter and year end 2014 financial results conference call Monday, March 23, 2015 at 1:30 p.m. PT / 4:30 p.m. ET for which the dial-in numbers are: 844-452-6826 (domestic) or 765-507-2587 (international); Conference ID: 5132313. Additionally, the live and archive webcasts will be available at http://investors.coherus.com.