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# FDA Accepts Coherus Application for Neulasta Biosimilar
- URL: https://www.fdaweb.com/fda-accepts-coherus-application-for-neulasta-biosimilar/
- Published: 2016-10-07T12:00:00.000Z
- Updated: 2026-09-14T21:38:09.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5137026

FDA has accepted a Coherus BioSciences BLA for CHS-1701, a pegfilgrastim (Amgen’s Neulasta) biosimilar candidate. The product is indicated for helping to reduce the chance of infection due to a low white blood cell count, in people with certain types of cancer (non-myeloid) who receive anti-cancer medicines (chemotherapy) that can cause fever and low blood cell count. The submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta, according to the company. The user fee review action date is 6/9/2017.