On day 2 of the AAM GRx+Biosims conference, a learning track regarding FDA Expectations for Biosimilar Manufacturing Inspections was presented by members from both the FDA and private industry.  Speakers included: Chris Downey, Ph.D., Division Director, CDER; Shawn Allwein, Ph.D., Vice President Biologics CMC, Teva; and Michael Cutter, Ph.D., Chief Quality Officer, Biocon. 

Dr. Downey opened up the session with a discussion on the complexity of inspecting biosimilar facilities, noting that biosimilars are subject to the same rules and regulations as biologics.  As biosimilars are only subject to approval after a Pre-License Inspection (PLI), a biosimilar product should expect to be inspected directly by CDER staff who are trained specifically in this type of inspection.  One key point that Dr. Downey made was that it is highly important for CDER to see that a company has already audited itself, identified and documented CAPAs, and has been proactive about quality ahead of the biosimilar inspection. 

Following the FDA layout of biosimilars inspections, Dr. Allwein discussed effective preparation strategies for pre-approval inspections (PAIs) and PLIs, touting four primary steps: 

    1. Document your current status. 
    2. Perform an assessment based on current regulations. 
    3. Undertake training and storyboarding to assist and drive the inspection. 
    4. Perform a mock inspection and prepare a remediation report.


The session culminated with a talk from Dr. Cutter focused on Quality Management Maturity (QMM).  The key point that he made was about a company’s responsibility in operating to more than just the current GMPs, with his message being that you should always be operating to the intended future of the practices and regulations.  Dr. Cutter stressed the rule of three as applied to QMM, with the three being: 

  • Patient Focused (highlighted by reference to a specific patient who had phase 4 cancer and could not get the medication she needed) 
  • Proactive 
  • Continually Improving 

Overall, the talk had some good takeaways that can be valuable to quality management in all biosimilar-product organizations.  If you are looking to perform a mock inspection, assess your QMM, or talk about the complex regulations and regulatory affairs of biosimilars, we can help.  Contact us at LCS@LachmanConsultants.com.