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Coherus BioSciences says Neulasta biosimilar shows positive topline results; shares jump

Published on 12/07/16 at 07:57am

Shares in Coherus BioSciences (Nasdaq: CHRS) jumped to close over 27% after the company said its biosimilar copy for Amgen’s (Nasdaq: AMGN) cancer drug Neulasta (pegfilgrastim) met all of its co-primary endpoints in a follow-on drug study.

The company said it expects to start commercial plans and preparations for the biosimilar candidate, CHS-1701, later this year.  

Barbara Finck, chief medical officer of Coherus BioSciences, said: “As has been seen, pegfilgrastim is a relatively biologically complex molecule.  Our novel and innovative study design allowed us to evaluate and successfully control for the contribution of subject variability to the PK/PD parameters, validating our hypothesis regarding the outliers seen in the earlier study.  Based on the totality of the data, including this clinical result as well as those from the previous PK/PD study and the successful immunogenicity study, we are confident that CHS-1701 is highly biosimilar to the reference product, Neulasta, and will produce the expected clinical effect in patients.”

There were no serious adverse events related to either study drug or clinical meaningful difference between CHS-1701 or Neulasta leading to study drug discontinuations, Coherus said in a statement.

Anjali Shukla   

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