Drug news
CHS-1701 (pegfilgrastim Neulasta biosimilar) filed with FDA for neutropenia - Coherus BioSciences
Coherus BioSciences announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate for neutropenia, 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.
Comment; The EU patent for Neulasta expires in August 2017 and the US patent expired in October 2015.
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