Coherus delaying Neulasta biosimilar submission

Coherus BioSciences Inc. (NASDAQ:CHRS) fell $3.90 (14%) to $24.30 on Wednesday after it said it will delay its planned submission of a BLA for CHS-1701 by about three months to conduct an additional pharmacokinetic and pharmacodynamic study. Coherus said last month that it planned to submit a BLA in 1Q16 for the biosimilar of Neulasta pegfilgrastim.

The company said it expects that the new study in healthy volunteers, which FDA did not request, will cost less than $4 million. ...