SPC review for Bibliographic products

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    Jacqueline Winston


    I am currently preparing an annual safety review for one of my company’s generic products and as part of this would normally do a review of our SPC against the reference product’s SPC.  However, the licence for the product in question was submitted as a bibliographic licence so there is no reference product.  I have looked for another product on the market for the comparison, but ours is the only injectable version of this active.  Could anyone advise what I should do in this situation please?  Would it be enough to compare to an oral version of the product of the same strength?  I’m aware the safety profile would be slightly different given the difference in administration routes, but the general side effect profile should be similar.  Any thoughts?


    Thank you!

    Dora Amene

    Please note, that the response to your query represents the opinions formed from a consensus of the PIPA Committee, but do not represent their employing companies. These responses are intended as guidance. Please also refer to guidelines and your own company procedures.  

    Dear Member,

    Thank you for your enquiry regarding SPC review for Bibliographic products.

    One could compare an oral formulation with  injectable form with some rationale – if toxicity is Cmax driven, then it is likely that an injectable form will have higher Cmax, if it is AUC driven, then most of the toxicity for an injectable could be anticipated for oral, but there would be no local injection reactions or infusion reactions.

    Kind regards


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