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Coherus' Udenyca (pegfilgrastim-cbqv) Receives the US FDA Approval for Patients Receiving Myelosuppressive Chemotherapy

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Coherus' Udenyca (pegfilgrastim-cbqv) Receives the US FDA Approval for Patients Receiving Myelosuppressive Chemotherapy

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  • Post EU Approval- Udenyca has received FDA approval on basis of non-inferiority data including its PK- PD and immunogenicity in 600 healthy patients- receiving myelosuppressive CT having cancer
  • Udenyca novel pegfilgrastim-cbqv biosimilar- has received its EU approval on 21 Sep- 2018. In 2017- Pegfilgrastim had $4.5B sales worldwide
  • Udenyca (formerly CHS-1701) is a PEGylated growth colony-stimulating factor indicated to reduce chances of infection by febrile neutropenia

Ref: Reuters| Image: Marketing91


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