Biosimilar Product Approval Process Checklist Form
Use this form to review whether a biosimilar product has the required documentation and readiness items for approval submission. No emojis. Use the exact same title consistently across the form.
Product Identification
Biosimilar Product Name
*
Reference Biologic / Comparator Product Name
*
Dosage Form and Strength
*
Manufacturer / Applicant Organization Name
*
Approval Checklist
Completed quality documentation
*
Yes
Analytical similarity data available
*
Yes
Nonclinical comparability reviewed
*
Yes
Clinical comparability reviewed
*
Yes
Manufacturing process validated
*
Yes
Submission Tracking
Submission Status
*
Draft
Internal Review
Ready for Submission
Submitted
Under Agency Review
Need Revisions
Approved
Other
Target Submission Date
 -
Month
 -
Day
Year
2 digit month, 2 digit day, 4 digit year
Date
Submit
Should be Empty: