Coherus’ application for pegfilgrastim biosimilar accepted by EMA

November 30, 2016 11:20 AM

Coherus BioSciences, Inc. 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.”

 

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