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Re: DragonBits post# 9295

Tuesday, 03/18/2008 6:16:08 PM

Tuesday, March 18, 2008 6:16:08 PM

Post# of 19309
Somwhere along the line you got terribly lost.

<<Then for a drug currently under production, there are the sunk costs of the bioreactors already being used. If one is producing enough drugs with bioreactors, why switch?>>

In a nutshell, lower cost. The "biosimilar" would probably be produced by another company ... a competitor ... not the original manufacturer. After the original patent expired, if a competitor could produce the drug by an alternate method ... which would have to be approved ... at a lower cost, then the competitor could sell the drug for less and probably gain a large share ... possibly all ... of the market. If not, the competitor probably would not even try.

There is currently no way to get a "biosimilar" approved in the United States. Congress will have to pass enabling legislation and the FDA will have to adopt rules. That is expected to happen in a year or so.

As things stand today, your scenario makes no sense.



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