Shots:
- FDA has approved Filkri, a biosimilar to Neupogen (filgrastim), for pts receiving myelosuppressive CT, those with AML receiving induction or consolidation CT, cancer pts undergoing bone marrow transplant, pts with sev. chronic neutropenia, & pts exposed to myelosuppressive radiation
- Approval was supported by 2 studies in healthy adults, with PK/PD assessed in one, & safety & immunogenicity evaluated in both against Neupogen, showing comparable PK/PD profiles, along with similar safety & immunogenicity outcomes
- Accord has also applied for a permanent Q-code from the US CMS to streamline & standardize billing & reimbursement procedures across various settings
Ref: PRnewswire | Image: Accord | Press Release
Related News: Accord BioPharma Receives the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)
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