Confirmed biosimilarity of ZARXIO to NEUPOGEN® (filgrastim)1,2
Biosimilarity was confirmed by the PIONEER study and a PK/PD study that demonstrated equivalence with regard to ANC* and CD34+ cell counts1,2
PIONEER was a randomized, double-blind, comparative study of efficacy and safety between ZARXIO and NEUPOGEN® in 218 breast cancer patients treated with myelosuppressive chemotherapy.2†
- Study duration: 24 weeks1
- All patients received 6 cycles (3 weeks per cycle) of TAC‡ combination chemotherapy administered on Day 1 of each cycle2
- Starting on Day 2 of each chemotherapy cycle, ZARXIO or NEUPOGEN® was administered daily and continued until the ANC recovered to 10 x 109/L after the nadir or up to a maximum of 14 days (whichever occurred first)
- The study included 4 arms in total2
- 2 arms received treatment with either ZARXIO or NEUPOGEN® across all cycles
- 2 arms started with either ZARXIO or NEUPOGEN® in Cycle 1, then alternated treatment in each subsequent cycle
Study design
Efficacy
Primary endpoint for equivalence (in Cycle 1): mean duration of severe neutropenia (DSN)1,4§
Biosimilarity demonstrated through the totality of evidence5
ANC profiles of ZARXIO and NEUPOGEN®2
No antibodies against rhG-CSF were detected throughout the PIONEER study for either ZARXIO or NEUPOGEN®.2
Safety
Cardinal adverse events (between-group comparison)4
Treatment-emergent adverse events (TEAEs) >5% in Cycle 11
The overall safety profile of ZARXIO was similar across all 6 cycles with continuous treatment.4
Prescribing Information adverse reactions6
The following most common adverse reactions listed in the ZARXIO Prescribing Information are based on the reference biologic.
ADVERSE REACTIONS
- Most common adverse reactions in patients:
- With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are thrombocytopenia, nausea, pyrexia, chest pain, pain, fatigue, back pain, arthralgia, bone pain, pain in extremity, dizziness, cough, dyspnea, rash, blood lactate dehydrogenase increased and blood alkaline phosphatase increased
- With AML (≥ 2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, and rash maculo-papular
- With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) are rash and hypersensitivity
- Undergoing peripheral blood progenitor cell mobilization and collection (≥ 5% incidence) are bone pain, pyrexia, blood alkaline phosphatase increased and headache
- With severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia
CONTRAINDICATIONS6
- Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim products
WARNINGS AND PRECAUTIONS6
- Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture
- Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue ZARXIO in patients with ARDS
- Serious allergic reactions, including anaphylaxis: Permanently discontinue ZARXIO in patients with serious allergic reactions
- Fatal sickle cell crises: Have occurred
- Glomerulonephritis: Evaluate and consider dose-reduction or interruption of ZARXIO if causality is likely
USE IN SPECIFIC POPULATIONS6
- ZARXIO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
- It is not known whether filgrastim products are excreted in human milk
ZARXIO is a registered trademark of Novartis AG.
NEUPOGEN is a registered trademark of Amgen Inc.