Regulatory Open Forum

 View Only

  • 1.  New company taking over BLA

    Posted 29-Dec-2016 14:42

    Does anybody have any experience with this situation?  Company A received BLA a long time ago, then due to business reasons takes product off market a couple years ago.  Company B wants to put Company A's product back on the market.  Aside from commercial licensing or sale of the product, I presume Company B will need to get their own BLA.  Is that correct?  Will company B need to file a new BLA or some kind of supplemental BLA?  I assume they will need any new manufacturing site inspected as part of it as well.

    ------------------------------
    Debbie Koeneman
    Consultant
    Mesa AZ
    United States
    ------------------------------


  • 2.  RE: New company taking over BLA

    Posted 30-Dec-2016 16:20

    The regulations 21 CFR 314.72 provide for transfer of ownership of an application.  I would anticipate that FDA would assign a new number to the BLA.  The prior owner and the new owner need to make certain declarations about the transfer process and responsibilities going forward about maintaining the approved application.  Any changes to the existing application need to be submitted to FDA as part of the post-approval regulations.

    Regards,

    ------------------------------
    Michael Trapani
    Senior Consultant
    Biologics Consulting Group, Inc.
    Belle Mead NJ
    United States

    Original Message


  • 3.  RE: New company taking over BLA

    Posted 03-Jan-2017 10:52

    Hi Debbie

     

    A few years back my company divested/sold our two BLA's to another company.  The new company would need a US License # if they don't already have one to market biologics.  This is different than the BLA #.  In our case, we also had to request FDA to revoke our US License since we would no longer have any BLAs.  I believe the US License # is a 4 digit #.  The BLA would transfer from Company A to Company B and I don't think the BLA # would change.  A subsequent supplement to the BLA would only need to be filed by Company B if they are making changes. You mention a manufacturing site change – this would require a supplement and most likely an inspection.

     

    Regards

    Tom




    Original Message


Related Content