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Re: genisi post# 123710

Thursday, 01/19/2012 7:27:49 AM

Thursday, January 19, 2012 7:27:49 AM

Post# of 257268
NVS starts phase-3 trials for Neupogen/Neulasta FoB’s:

http://www.novartis.com/newsroom/media-releases/en/2012/1578463.shtml

These programs seek FDA regulatory approval via the traditional BLA pathway, not the new 351(k) pathway, which implies that they will be non-substitutable for the corresponding branded products from AMGN.

Teva is also a player in the market for Neopogen/Neulasta FoB’s, and it reached a partial patent settlement with AMGN (#msg-65841959, #msg-65308970).

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