Hi Anonymous,
I am not aware of any FDA-issued checklist, but I make a lot of submissions checklists for my clients (mainly to help me assess how much information they actually have to support a submission). My method of developing checklists is to go through the guidance and highlight anything that needs to be included in a submission, then draw up the checklist based on at least two, and sometimes more than three guidance documents. That being said, the following guidance documents tell you most everything you need to know:
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
- Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
If you go through those three documents plus the Q&A guidance documents and highlight the details that the guidance requires in a submission, you will have all you need to create your own checklist. Slide decks from FDA presentations are also very helpful.
Best of luck,
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Arvilla Trag RAC
Principal Consultant
CMC Compliance Services
Iron River MI
United StatesCMC Compliance Services LLC
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Original Message:
Sent: 25-Mar-2024 12:43
From: Anonymous Member
Subject: BLA Submission Checklist
This message was posted by a user wishing to remain anonymous
Hi All,
Is anyone aware of a checklist or other document similar to the ANDA Filing Checklist that could be used for the preparation of a BLA (351(k))? There doesn't seem to be a MAPP containing one.
Thank you!