REDWOOD CITY, CA, USA I November 29, 2016 I Coherus BioSciences, Inc. (CHRS), today announced acceptance of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This represents the first EMA submission and acceptance for Coherus BioSciences.
The CHS-1701 MAA is supported by biosimilarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.
“The CHS-1701 MAA submission marks our first to the EMA and follows our CHS-1701 filing with the FDA. We believe this filing provides the basis for good partnering opportunities for CHS-1701 in the European markets in the first half of 2017,” said Denny Lanfear, President and CEO of Coherus BioSciences. “We will continue to focus on strong execution across all aspects of the business plan and look forward carrying this momentum into next year.”
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar 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 in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences
Post Views: 34
REDWOOD CITY, CA, USA I November 29, 2016 I Coherus BioSciences, Inc. (CHRS), today announced acceptance of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This represents the first EMA submission and acceptance for Coherus BioSciences.
The CHS-1701 MAA is supported by biosimilarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.
“The CHS-1701 MAA submission marks our first to the EMA and follows our CHS-1701 filing with the FDA. We believe this filing provides the basis for good partnering opportunities for CHS-1701 in the European markets in the first half of 2017,” said Denny Lanfear, President and CEO of Coherus BioSciences. “We will continue to focus on strong execution across all aspects of the business plan and look forward carrying this momentum into next year.”
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar 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 in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences
Post Views: 34
