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One of the issues hanging over the FDA is what to do about 'biotechnolgy' products like proteins and mabs coming off of patent. There is currently no set mechanism to recognize generics based on biologically derived products i.e. it is not so straightforward (or even necessary) to prove they are 'identical' to the originals such as with small molecule drugs.

Novartis is well positioned in my opinion to take advantage of the 'biosimilars' market if, no make that when, it emerges.

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