FULPHILA® is an effective treatment option for patients with febrile neutropenia

For FDA approval, FULPHILA was demonstrated to be highly similar to an existing FDA-approved biological product referred to as the reference product or reference biologic.

“FDA requires biosimilar…products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar…just as they would the reference product.” — FDA2

Studies demonstrated that pegfilgrastim* resulted in a 94% reduction in febrile neutropenia (FN) with patients receiving chemotherapy for up to 4 cycles

Study Design

Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer receiving 100 mg/m2 docetaxel for up to 4 cycles. Included 928 patients initially receiving placebo (n=465) or NEULASTA® (n=463). Primary endpoint was the percentage of patients who developed FN.1,3

Efficacy at par with the reference product4

Confirmatory Phase III study demonstrated equivalent efficacy to the reference product4 in the reduction of chemotherapy-induced febrile neutropenia in breast cancer patients.


Study Design

Randomized, double-blind, parallel-group trial evaluating equivalence of FULPHILA vs. reference pegfilgrastim in patients with breast cancer eligible to receive neoadjuvant or adjuvant TAC chemotherapy. The primary endpoint was the duration of severe neutropenia in cycle 1 defined as ANC < 0.5 x 109/L.
  1. Fulphila® (pegfilgrastim-jmdb) injection. Prescribing information. 2023. Biocon Biologics Inc. Cambridge, MA.
  2. U.S. Food and Drug Administration. Biosimilars. Available at:
    Accessed on: 10 August 2023.
  3. Vogel C, et al. J Clin Oncol. 2005;23:1178-1184.
  4. Waller, C.F., Ranganna, G.M., Pennella, E.J. et al. Ann Hematol. (2019) 98: 1217.

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