Table.
FDA's Biosimilar Requirements and Filgrastim-sndz
| Statutory requirement | Fulfillment of requirement | |
|---|---|---|
| Demonstrates high similarity | Analytical data | Studies demonstrate that filgrastim-sndz has the same amino acid sequence as filgrastim Functional properties (biological activity, receptor binding) and physicochemical properties (higher-order structure, product-related substances, impurities) of filgrastim-sndz are highly similar to that of filgrastim Filgrastim-sndz has a similar stability profile as filgrastim |
| Animal studies | Five animal studies confirmed that the pharmacologic and toxicologic profiles of filgrastim-sndz and filgrastim are similar | |
| Clinical studies | Four pharmacokinetic and pharmacodynamics studies evaluated SC doses of 1–10 mcg/kg of filgrastim-sndz and filgrastim in healthy individuals; these studies included absolute neutrophil count and CD34+ cell counts as markers of neutropenia and mobilization of hematopoietic stem cells. All comparisons of filgrastim-sndz and filgrastim met prespecified criteria for analytical similarity Safety data were evaluated in 204 healthy individuals and in 214 patients with breast cancer; the safety profile of filgrastim-sndz was similar to that of filgrastim One study (PIONEER) compared the efficacy and safety of filgrastim-sndz with filgrastim in 218 patients with breast cancer who received myelosuppressive chemotherapy |
|
| Same as reference drug | Mechanism of action | The mechanism of action of filgrastim is mediated by selective binding to the G-CSF receptor and is similar across all labeled indications |
| Route of administration, dosage form, and strength | Filgrastim-sndz has the same routes of administration, dosage forms, and strengths as filgrastim |
G-CSF indicates granulocyte colony-stimulating factor; SC, subcutaneous.
Sources: Sandoz. www.zarxio.com/info/hcp/pioneer.jsp; US Food and Drug Administration. www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm436953.htm; Zarxio (filgrastim-sndz) injection prescribing information; August 2015; Stanton D; for BioPharma-Reporter. www.biopharma-reporter.com/Markets-Regulations/Biosimilars-land-in-the-US-as-Sandoz-launches-Zarxio.