Coherus BioSciences has announced that it has submitted a biologics license application (BLA) for CHS-1701 to the U.S. Food and Drug Administration (FDA) under the pathway of 351(k).
CHS-1701 is a pegfligrastim biosimilar candidate.
“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,” Coherus President and CEO Danny Lanfear said. “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.”
Coherus moved forward with the submission of the BLA based on data recorded from analytical, pharmacokinetic, pharmacodynamics and immunogenicity studies that compared CHS-1701 to Neulasta.
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