Unlike MNTA, CHRS acknowledges that the existing formulation of its Humira FOB infringes ABBV's US patents. CHRS is therefore developing a new Humira-FoB formulation and will submit its 351(k) application when the reformulation work is done.
How will the FDA handle a 351(k) application where the phase-3 data pertain to a different formulation? I don't know. As a MNTA (but not a CHRS) shareholder, I'm glad I don't have this concern.
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