Pegfilgrastim Follow-on PK/PD Study Added to Bolster BLA Submission Package
REDWOOD CITY, CA, USA I December 08, 2015 I Coherus BioSciences, Inc. (CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced an update to its CHS-1701 clinical program.
“The recent pharmacokinetic/pharmacodynamic (PK/PD) study is acceptable to support filing the Biologics License Application (BLA). However, given the low cost and relatively short delay involved, it is most prudent to initiate a follow-on study in healthy volunteers. We believe this will remove any residual uncertainty, reduce regulatory risk and potential for BSUFA timeline delays, and ultimately increase the likelihood of first cycle approval of CHS-1701,” said Denny Lanfear, president and chief executive officer of Coherus.
Coherus estimates that the follow-on study will cost less than $4 million and entail about a quarter delay in projected BLA filing timing.
“We have performed an extensive root cause analysis to identify the implicating factors for the key outliers in the recently completed PK/PD bioequivalence study. Although this analysis is on-going, through this work, we have ruled out drug mishandling, sample mishandling, assay performance, and the possibility that study conduct issues contributed to the anomalous Neulasta® result,” said Barbara Finck, M.D., chief medical officer. “Pegfilgrastim inherently has a variable PK profile. We have seen this in numerous published studies as well as in our own studies. Our exhaustive investigation provides us with a solid understanding of study factors that may be incorporated to reduce patient variability and address the inherent variability of Neulasta.”
“Our objective is to file a high quality regulatory package to facilitate approval in the most expeditious timeframe possible. Given the strong analytical profile, robust CMC package, and positive clinical performance of CHS-1701 in the recent PK/PD study, we are confident the follow-on study will support this objective. Considering the product’s overall value proposition in context of the current competitive environment, we believe this approach is most judicious for medium- to long-term value creation,” said Denny Lanfear.
Coherus will hold a conference call on Tuesday, December 8, at 5:30 p.m. ET.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences
Post Views: 347
Pegfilgrastim Follow-on PK/PD Study Added to Bolster BLA Submission Package
REDWOOD CITY, CA, USA I December 08, 2015 I Coherus BioSciences, Inc. (CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced an update to its CHS-1701 clinical program.
“The recent pharmacokinetic/pharmacodynamic (PK/PD) study is acceptable to support filing the Biologics License Application (BLA). However, given the low cost and relatively short delay involved, it is most prudent to initiate a follow-on study in healthy volunteers. We believe this will remove any residual uncertainty, reduce regulatory risk and potential for BSUFA timeline delays, and ultimately increase the likelihood of first cycle approval of CHS-1701,” said Denny Lanfear, president and chief executive officer of Coherus.
Coherus estimates that the follow-on study will cost less than $4 million and entail about a quarter delay in projected BLA filing timing.
“We have performed an extensive root cause analysis to identify the implicating factors for the key outliers in the recently completed PK/PD bioequivalence study. Although this analysis is on-going, through this work, we have ruled out drug mishandling, sample mishandling, assay performance, and the possibility that study conduct issues contributed to the anomalous Neulasta® result,” said Barbara Finck, M.D., chief medical officer. “Pegfilgrastim inherently has a variable PK profile. We have seen this in numerous published studies as well as in our own studies. Our exhaustive investigation provides us with a solid understanding of study factors that may be incorporated to reduce patient variability and address the inherent variability of Neulasta.”
“Our objective is to file a high quality regulatory package to facilitate approval in the most expeditious timeframe possible. Given the strong analytical profile, robust CMC package, and positive clinical performance of CHS-1701 in the recent PK/PD study, we are confident the follow-on study will support this objective. Considering the product’s overall value proposition in context of the current competitive environment, we believe this approach is most judicious for medium- to long-term value creation,” said Denny Lanfear.
Coherus will hold a conference call on Tuesday, December 8, at 5:30 p.m. ET.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences
Post Views: 347
