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About Fylnetra

Fylnetra® from Amneal Biosciences

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.

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Indications

Fylnetra is a leukocyte growth factor indicated to:

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.

Fylnetra® Robust Evidence

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The clinical development program for Fylnetra® (TPI-120) was comprised of a pivotal comparative PK/PD study (TPI-CL-109-A) in healthy volunteers performed with US-licensed Neulasta as the reference product and an immunogenicity and safety study (ADL-CL-112) conducted in healthy subjects.1

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

  • Statistical analysis of the PK parameters demonstrated similarity between Fylnetra® and Neulasta®
  • Secondary PK parameters included the residual area (AUC%extrap), Tmax, T½el and Kel for serum
  • Fylnetra® was generally well tolerated by healthy subjects

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

  • Pharmacodynamic similarity of Fylnetra® versus Neulasta® was established for ANC (absolute neutrophil count) in the PK/PD study where bioequivalence was established1
  • Secondary PD parameters included baseline-corrected Tmax,E for ANC
  • The safety, tolerability, and immunogenicity profile of Fylnetra® and Neulasta® was determined to be similar

References:

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