Tags : Udenyca

Biosimilars Regulatory

Coherus’ Udenyca (pegfilgrastim-cbqv) Receives the US FDA Approval for Patients

Shots: 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 […]Read More

Biosimilars Regulatory

Coherus Biosciences’ Udenyca (Pegfilgrastim Biosimilar) Receives EU Marketing Approval for

Shots: Udenyca’s (Pegfilgrastim biosimilar) EU approval is based on the data demonstrating its PK and PD, for reducing the chances of infection by febrile neutropenia This biosimilar is currently under the US FDA inspection and has provided a PDUFA date 3 Nov, 2018. Udenyca is currently not available for commercial sale Udenyca (pegfilgrastim-cbqv/CHS-1701), is a […]Read More