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BIA, BPD 1,2,3,4 vs Pre-IND, Type A, B, C Meeitng

  • 1.  BIA, BPD 1,2,3,4 vs Pre-IND, Type A, B, C Meeitng

    Posted 09-Sep-2020 12:40
    Hello Everyone,

    I'm trying to understand the meeting request timeline with respect to biosimilar development.  I'm trying to figure out what is needed for a BE study for a biosim.  I assume an IND is required.  Is the Pre-IND meeting considered to be the BPD Type 2?

    Kind regards,
    Ken

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    Ken Rose
    Painesville OH
    United States
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