No big switch at all.
In nov 2006 insm allready started hiring more with biogenerics in mind.
The company IS test producing various drugs that would go off patent and is spending research time and money there.
The FDA was very much ok with their production facility and process for a very complex biologic to make (ie IGFBP3).
this is science and production knowledge that very few companies posses, and that is why insm started pursuing it.
key here is the US fda approval seal, and key is the political will to see some guidelines ... which we will see this summer.
That means that based on those guidelines, FDA guidelines can be interpreted and talks can be more specific since the companies than can more easily predict what will be ahead (in terms of phase I testing required etc) and what costs that would entail, thus indeed providing enough information to make an informed agreement.
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