PharmPK Discussion - Protein Variation

• On 7 Mar 2008 at 00:02:54, "Avi Gordon" (agordon.-a-.smile.net.il) sent the message
  

  
  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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• On 7 Mar 2008 at 23:14:20, Mark Milton (markmiltonpharmaceutical.aaa.gmail.com) sent the message
  

  
  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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