The Meals and Drug Management (FDA) has licensed a brand new single-dose prefilled autoinjector presentation of UdenycaÂ® (pegfilgrastim-cbqv), a biosimilar to Neulasta.
Udenyca is licensed to lower the prevalence of an infection, as manifested by way of febrile neutropenia, in sufferers with non-myeloid malignancies receiving myelosuppressive anticancer medicine related to a clinically vital prevalence of febrile neutropenia. Additionally it is indicated to extend survival in sufferers acutely uncovered to myelosuppressive doses of radiation.
Consistent with Coherus, the approval of the prefilled autoinjector was once supported by way of a complete analytical information bundle, along side a pharmacokinetic, pharmacodynamic and immunogenicity learn about. The only-dose prefilled autoinjector is anticipated to be to be had in the second one quarter of 2023 and can be utilized for each in-clinic and at-home management.
The Corporate may be expecting approval of Udenyca delivered by way of an on-body injector instrument this yr. Information from an open-label, crossover learn about confirmed pharmacokinetic and pharmacodynamic bioequivalence of Udenyca when administered by way of the on-body injector vs a prefilled syringe.
FDA approves UdenycaÂ® autoinjector. Information launch. Coherus BioSciences, Inc. Accessed March 6, 2023. https://www.globenewswire.com/news-release/2023/03/06/2621056/33333/en/FDA-Approves-UDENYCA-Autoinjector.html.
This text at the beginning seemed on MPR
Log in to proceed studying this text.
Donât fail to notice these daysâs most sensible content material on The Clinical Bag. Check in at no cost and acquire limitless get right of entry to to the most recent in scientific information, and way of life and trade recommendation, with customized day by day selections for you. There is something for each well being care skilled on The Clinical Bag.
Need to learn extra?
Please login or sign in first to view this content material.