AI
Friday, November 06, 2020 9:36:25 PM
Iryo
You cannot compare the labels directly--in the case of the vascepa they are referring to either 500mg or 1g 96% pure EPA, with the rest of the weight made up by excipients.In the case of Lovaza they are referring to the whole entire preparation, i.e. EPA + DHA + ALL "INACTIVE" INGREDIENTS IN THE WEIGHT described in the label. It goes back to the prior fight over the NCE exclusivity determination between Lovaza containing EPA, and Vascepa being a pure Iccosapent ethyl ester, an dthe definitions of active moiety and active ingredient. Here is a pictorial summary. You will appreciate the irony that the court actually makes the argument that the excipients may be the active ingredient in the overall Lovaza effect and not just the omega 3 components (LOL).
Personally,I believe since the FDA makes the statement in their 05/2020 ANDA approval letter that the Hikma generic icospent ethyl is "therapeutically equivalent and bioequivalent"--I would test the statement in reality. Amrn could easily test the HIKMA product against Vascepa for serum EPA levels and Tg effects in a small trial of 50 patients with 2x2 crossover design bw the two and see if HIKMA generic IPE really is bioequivalent or therapeutically equivalent as made and distributed? Since their API manufcaturers will undoubtedly be changed around and be multiple, we can expect variations in "biological equivalence" --how much is the question....
You cannot compare the labels directly--in the case of the vascepa they are referring to either 500mg or 1g 96% pure EPA, with the rest of the weight made up by excipients.In the case of Lovaza they are referring to the whole entire preparation, i.e. EPA + DHA + ALL "INACTIVE" INGREDIENTS IN THE WEIGHT described in the label. It goes back to the prior fight over the NCE exclusivity determination between Lovaza containing EPA, and Vascepa being a pure Iccosapent ethyl ester, an dthe definitions of active moiety and active ingredient. Here is a pictorial summary. You will appreciate the irony that the court actually makes the argument that the excipients may be the active ingredient in the overall Lovaza effect and not just the omega 3 components (LOL).
Personally,I believe since the FDA makes the statement in their 05/2020 ANDA approval letter that the Hikma generic icospent ethyl is "therapeutically equivalent and bioequivalent"--I would test the statement in reality. Amrn could easily test the HIKMA product against Vascepa for serum EPA levels and Tg effects in a small trial of 50 patients with 2x2 crossover design bw the two and see if HIKMA generic IPE really is bioequivalent or therapeutically equivalent as made and distributed? Since their API manufcaturers will undoubtedly be changed around and be multiple, we can expect variations in "biological equivalence" --how much is the question....
