"As stated in my prior post, if a drug obtains regulatory approval without relying, in whole or in part, on the clinical data of another drug, then it is not a FoB or biosimilar––it is simply a branded drug."
OK, so how does a company proceed to demonstrate to the FDA that their drug is biosimilar to one that is already approved? Is it simply by demonstrating that the composition is one and the same? If that is the case, then what distinguishes biosimilar from generic as we have been accustomed to? Or is it that I am totally misunderstanding the concept of an FoB and that an FoB may be targeting a different application that the one already on the market?
News 
Market Data 
Discover 
AI
