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  4. Use of Biosimilar-Specific Stability Data
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Use of Biosimilar-Specific Stability Data

Scheduled Pinned Locked Moved Claims & Support/References for Claims
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  • C Offline
    C Offline
    cscholes
    wrote last edited by
    #1

    Can we use a stability study designed for our biosimilar since the reference drug information in the product monograph does not reflect our data? Are there exceptions to the standard requirement of reflecting the product monograph for biosimilars?

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