Coherus BioSciences, Inc. announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to U.S. FDA under the 351(k) pathway.
The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.
“The CHS-1701 BLA submission marks a significant milestone in our ongoing transition to a commercial company in a transformational year for Coherus as we continue to focus on execution of our strategic plan,” said Denny Lanfear, President and CEO of Coherus BioSciences. “Pegfilgrastim is the largest selling oncology product in the U.S., and CHS-1701 is the cornerstone of our oncology franchise.
We believe we have a strong, competitive and order-of-entry position with this product. We anticipate our oncology portfolio to include an Avastin® biosimilar, as well as other oncology biosimilar product candidates.”
