Business Context and Reporting Period
Company: Coherus BioSciences, Inc.
Filing Type: Form 8-K (Current Report)
Date of Report: March 16, 2015
Subject: Receipt of FDA feedback regarding the Biologics License Application (BLA) clinical development program for CHS-1701, a pegfilgrastim biosimilar candidate.
Key Financial Metrics
This filing is a Current Report (Form 8-K) detailing a specific corporate event and does not contain financial statements. Consequently, the filing text does not provide clear values for revenue, profit, cash flow, margins, debt, or liquidity.
Material Changes
The material change reported is the receipt of written feedback from the U.S. Food and Drug Administration (FDA) on March 16, 2015, concerning the CHS-1701 development plan. As a result of this feedback, the Company initiated a pivotal pharmacodynamics and pharmacokinetics study.
Guidance, Outlook, and Management Commentary
- Development Plan: An additional immunogenicity study in healthy volunteers is planned pursuant to the BLA.
- Timeline: The immunogenicity study is projected to be concluded in 2015.
- Submission Outlook: The Company aims to submit the 351(k) biosimilar license application for CHS-1701 in Q4 2015 or Q1 2016.
- Disclaimer: The filing notes that the summary of FDA feedback is not a complete description of such feedback.
Investor Verification Checklist
- Verify the full details of the FDA feedback by reviewing the attached Press Release (Exhibit 99.1).
- Confirm the enrollment status and projected completion date of the newly initiated pivotal pharmacodynamics and pharmacokinetics study.
- Monitor the progress of the additional immunogenicity study in healthy volunteers to ensure the Q4 2015/Q1 2016 submission timeline remains viable.
- Review subsequent filings for any updates on the 351(k) license application status.