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BRIEF-Coherus Biosciences receives CRL from FDA for biologics license application for CHS-1701
June 12, 2017 / 10:49 AM / 5 months ago

BRIEF-Coherus Biosciences receives CRL from FDA for biologics license application for CHS-1701

June 12 (Reuters) - Coherus Biosciences Inc

* Coherus Biosciences receives complete response letter from fda for its biologics license application for chs-1701 (pegfilgrastim biosimilar candidate)

* Coherus will work with fda to address information requests

* Coherus Biosciences -crl primarily focused on fda request for a reanalysis of a subset of subject samples with a revised immunogenicity assay

* Coherus Biosciences inc - fda did not request a clinical study to be performed in oncology patients

* Coherus Biosciences inc says crl also focused on fda requests for certain additional manufacturing related process information

* Coherus Biosciences-‍crl does not indicate additional process qualification lots would be required or raise concerns on gmp status of chs-1701 bulk manufacturing Source text for Eikon: Further company coverage:

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