Fylnetra (pegfilgrastim-pbbk)1 injection is biosimilar to Neulasta® (pegfilgrastim). A recombinant granulocyte colony stimulating factor (rG-CSF).
Fylnetra is made entirely in the United States.
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Fylnetra is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Multiple in vitro analytical similarity studies using state-of-the-art orthogonal analytical methods demonstrated similarity between Fylnetra® and Neulasta® in key features such as: primary structure, molecular conformation, charge variants, protein content, purity, and biological activity.1,4
Comparative stability studies between Fylnetra® and Neulasta® under accelerated and forced degradation conditions have demonstrated similar behavior and degradation pathways for the two products.1,4
Fylnetra® clinical comparability included data from 120 healthy subjects evaluated in 1 PK/PD study and 230 healthy subjects in 1 immunogenicity/safety study:
1. Strong comparability PK package in healthy volunteer clinical study: The PK similarity of both products was established for serum filgrastim AUC0-t; AUC0-inf and Cmax.1,4
2. Strong Comparability PD package in healthy volunteer clinical study: As a surrogate for clinical efficacy, PD similarity of both products was established for baseline-corrected absolute neutrophil count (ANC) AUEC0-t and Emax for ANC:1,4
1. Fylnetra® Summary Basis of Approval – Drug Approval Package https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761084Orig1s000TOC.cfm
2. Food and Drug Administration, FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry, 2015.
3. Food and Drug Administration, FDA. Draft Guidance: Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations, 2019.
4. Fylnetra® Full Prescribing Information – https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=eeadd641-573d-47fe-897a-61006e5f9e03