Coherus BioSciences (CHRS) Completes Two Enbrel PK Studies
Get the Pulse of the Market with StreetInsider.com's Pulse Picks. Get your Free Trial here.
Coherus BioSciences, Inc. (Nasdaq: CHRS) announced results from two pharmacokinetic (PK) studies involving CHS-0214, a biosimilar candidate to etanercept (Enbrel).
CHS-0214-06 (‘06 Study) was a Phase 1 pharmacokinetic bioequivalence (PK BE) study comparing CHS-0214 vs. European Union (EU) Enbrel. The ‘06 Study achieved the primary PK BE endpoint, as the 90% confidence intervals for the geometric mean ratio for the two groups was within 80% to 125% for all PK parameters.
CHS-0214-07 (‘07 Study) is an additional, non-pivotal, Phase 1 bridging study. As anticipated, this study provided additional relative bioavailability data for CHS-0214. As planned, Coherus is moving forward with pre-submission meetings, now expected in the first quarter 2017, to review the complete CHS-0214 program prior to filing. The planned marketing authorizations submissions will occur directly thereafter.
“Coherus has successfully completed five clinical studies with CHS-0214 demonstrating similarity to Enbrel, including two pivotal Phase 3 studies in two separate indications and three PK studies. We look forward to discussing all data with EU regulators in the context of the overall program at the upcoming pre-submission meeting in preparation for the filing,” said Denny Lanfear, President and Chief Executive Officer of Coherus BioSciences.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Veracyte (VCYT) Announces Significant Data from Percepta Bronchial Genomic Classifier in Lung Cancer Screening
- DBV Technologies (DBVT) Announces Positive Viaskin CoFAR6 Study Results
- China Biologic Products (CBPO) Announces Acquisition of Full Guizhou Taibang Ownership
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!