The stated reason for the layoff is the CRL for CHRS' Neulasta FoB (#msg-132094293, #msg-132098831), but the delay in submitting the BLA for CHRS' Humira FoB (#msg-132511112) surely has something to do with it too.
CHRS now hopes to submit Humira FoB applications to both FDA and EMA in 2H18 (later than previously announced), using one of multiple formulations CHRS is still developing to work around ABBV’s formulation patents.
CHRS has found a new fill/finish CMO to handle product for both the FDA and EMA applications, addressing the issue disclosed in June (#msg-132511112).
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