Date: 2016-10-06
Type of information: Results
phase: 1
Announcement: results
Company: Coherus Biosciences (USA - CA)
Product: CHS-0214 (investigational etanercept biosimilar)
Action
mechanism: biosimilar/TNF alpha inhibitor/fusion protein. Etanercept is an anti-tumor necrosis factor (TNF) agent. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On October 6, 2016, Coherus BioSciences 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.
