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Dear Forum,
I would like to know how the authorities perceive a product based on
known and licensed recombinant protein drug with variation in three
amino acids. Would they treat it as variant protein or subtype? Would
they consider this a '"Follow - on Protein Product"?
Best regards,
Avi Gordon - Regulatory Affairs Director
Se-cure Pharmaceuticals Ltd.
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The following message was posted to: PharmPK
Avi,
If the change was deliberate (and even if it wasn't) it would most
likely be viewed as a new product. In other words, you wouldn't be
able to claim bioequivalence since the identity of the reference
product and your product would not be the same.
Regards
Mark Milton
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