I figured that’s what you meant. I know it’s functionally the same stuff, but that doesn’t make it generic. This is basically the same issue that likely faces follow-on biologicals (biogenerics, biosimilars, whatever you want to call them). If it’s not substitutable by the pharmacist, it’s not a true generic. The only way you’ll see the shift to the cheaper product is if the doctor writes a new prescription.

I don’t want to quibble about terminology, but the difference between a substitutable generic and a cheaper competing branded product is a big one.

fortical was approved through the pathway 505(b)2. They ran a 6 month trial fortical vs miacalcin. It showed that they acted the same way and got therefore the exact same label as miacalcin (go on and check it out). But as fortical uses recombnant sct, the FDA decided to not give them an AB rating with miacalcin. Therefore your point for not beeing therapeutically equivalent is true in “FDA technical” terms, but in regards to what it does to your health (same label!) it is equivalent and cheaper and therefore every one can urge his doctor to switch over to fortical. By the way, most healthplans see fortical as the generic to miacalcin. Only some medicaid commitees (most likely benefiting from either a discounted miacalcin price or is it just the members benefiting from some nice weekend trips?!, anyway) have it not as the generic on their list.

Fortical is not generic Miacalcin. It is recombinant calcitonin salmon and is not therapeutically equivalent.
What do you mean the patients are to blame?

Interestingly, Apotex has filed ANDAs for generic versions of both products and has been sued for infringement in both cases.

What an interesting game of chess.

If the end results show that it was Novartis who blocked this drug, I wonder if the outcome would be to pay back retribution to all patients who may have paid more than they should have because of the delay.

Interesting…