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Coherus BioSciences, Inc.

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COHERUS BIOSCIENCES ANNOUNCES FDA ACCEPTANCE OF 351(K) BIOLOGICS LICENSE APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR CHS-1701 (PEGFILGRASTIM BIOSIMILAR CANDIDATE)
REDWOOD CITY, Calif., Oct. 06, 2016 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading pure-play, global biosimilar company with late-stage clinical products, today announced that the U.S. FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate.

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta. The biosimilar user fee act (BSUFA) action date is June 9, 2017.
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Source: press release, 10/06/16. http://investors.coherus.com/phoenix.zhtml?c=253655&p=irol-newsArticle&I...

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COHERUS BIOSCIENCES SUBMITS 351(K) BIOLOGICS LICENSE APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION FOR CHS-1701 (PEGFILGRASTIM BIOSIMILAR CANDIDATE)
REDWOOD CITY, Calif., Aug. 09, 2016 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (NASDAQ:CHRS), today 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.”
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Source: press release, 8/09/16. http://investors.coherus.com/phoenix.zhtml?c=253655&p=irol-newsArticle&I...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
CHS-1701 (Neulasta)OncologyFebrile NeutropeniaGranulocyte Colony-Stimulating Factor (GCSF)Neutrophil progenitor

Mechanism of action: Neulasta (Pegfilgrastim) is a long-acting pegylated form of a recombinant therapeutic agent which is chemically identical to or similar to an endogenous human granulocyte colony-stimulating factor (G-CSF). Produced endogenously by monocytes, fibroblasts, and endothelial cells, G-CSF binds to and activates specific cell surface receptors, stimulating neutrophil progenitor proliferation and differentiation and selected neutrophil functions. Conjugation of the cytokine with a branched polyethylene glycol molecule (pegylation) significantly increases its therapeutic half-life.

Phase of Development: Filed

Event Type: Regulatory FDA: BsUFA DATE

Dates: 2017-06-09

Results: Pending