Biotech Values

[genisi]

Perhaps MRK's strategy to run full clinical programs and submit BLAs for its FoBs reflects its view that the FDA will require such pathway anyhow.
Shire is performing a full clinical program for its biosimilar GA-GCB just like it did with Dynepo. TevTropin was filed as an NDA following full clinical studies. But what if phase II studies will not be required at all, or like in Omnitrope's case which was approved after full phase III but no phase II dose ranging and less tox data.
Costs for developing a biosimilar will surely be higher than of a generic drug but possibly (not dramatically) lower than an innovator, imo.