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).
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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