Skip to main content

Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies.

Publication ,  Journal Article
Harbeck, N; Gascón, P; Krendyukov, A; Hoebel, N; Gattu, S; Blackwell, K
Published in: Oncologist
April 2018

BACKGROUND: Evaluation of adverse events (AEs) in pivotal registration trials and ongoing postmarketing surveillance is important for all biologics, including biosimilars. A combined analysis of two pivotal registration studies was performed to strengthen evidence on safety for biosimilar filgrastim EP2006 in patients with breast cancer receiving myelosuppressive chemotherapy, a sensitive clinical setting to confirm biosimilarity of filgrastim. MATERIALS AND METHODS: Data were combined from two phase III studies of biosimilar filgrastim EP2006. The U.S. registration study was a randomized, double-blind comparison of biosimilar and reference filgrastim in women aged ≥18 years with breast cancer, receiving (neo)adjuvant treatment with TAC (docetaxel + doxorubicin + cyclophosphamide). The European Union registration study was a single-arm, open-label study of biosimilar filgrastim in women aged ≥18 years with breast cancer receiving doxorubicin + docetaxel. Patients received filgrastim as a subcutaneous injection on day 2 of each cycle for <14 days or until the absolute neutrophil count reached 10 × 109/L after the expected nadir. Results were combined for cycles 1-4. RESULTS: A total of 277 patients received biosimilar filgrastim EP2006. Patients had a mean (± standard deviation) age of 51.1 (± 10.8) years, and 78.7% of patients had stage II or III breast cancer. A total of 46 (20.6%) patients receiving biosimilar filgrastim had AEs considered filgrastim-related. The most frequently reported filgrastim-related AEs were musculoskeletal or connective tissue disorders (15.2%), including bone pain (7.2%). One death (due to pulmonary embolism) occurred of a patient receiving biosimilar filgrastim (not considered filgrastim-related). No patient developed antidrug antibodies during the study. CONCLUSION: Biosimilar filgrastim has a safety profile consistent with previous filgrastim studies and is effective in preventing febrile neutropenia in patients with breast cancer. IMPLICATIONS FOR PRACTICE: The biosimilar filgrastim EP2006 (Zarzio, Zarxio, biosimilar filgrastim-sndz) has been approved in Europe since 2009 and in the U.S. since 2015. This combined analysis of two phase III studies provides additional clinical evidence that the biosimilar filgrastim EP2006 has a safety profile consistent with previous studies of reference filgrastim and supports large postmarketing studies of EP2006 in Europe. Strengthening the evidence for biosimilar filgrastim can help improve acceptance of biosimilars and increase patient access to biologics.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Oncologist

DOI

EISSN

1549-490X

Publication Date

April 2018

Volume

23

Issue

4

Start / End Page

403 / 409

Location

England

Related Subject Headings

  • Treatment Outcome
  • Safety
  • Oncology & Carcinogenesis
  • Neutropenia
  • Neoplasm Staging
  • Neoadjuvant Therapy
  • Middle Aged
  • Humans
  • Hematologic Agents
  • Filgrastim
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Harbeck, N., Gascón, P., Krendyukov, A., Hoebel, N., Gattu, S., & Blackwell, K. (2018). Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies. Oncologist, 23(4), 403–409. https://doi.org/10.1634/theoncologist.2017-0348
Harbeck, Nadia, Pere Gascón, Andriy Krendyukov, Nadja Hoebel, Sreekanth Gattu, and Kimberly Blackwell. “Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies.Oncologist 23, no. 4 (April 2018): 403–9. https://doi.org/10.1634/theoncologist.2017-0348.
Harbeck N, Gascón P, Krendyukov A, Hoebel N, Gattu S, Blackwell K. Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies. Oncologist. 2018 Apr;23(4):403–9.
Harbeck, Nadia, et al. “Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies.Oncologist, vol. 23, no. 4, Apr. 2018, pp. 403–09. Pubmed, doi:10.1634/theoncologist.2017-0348.
Harbeck N, Gascón P, Krendyukov A, Hoebel N, Gattu S, Blackwell K. Safety Profile of Biosimilar Filgrastim (Zarzio/Zarxio): A Combined Analysis of Phase III Studies. Oncologist. 2018 Apr;23(4):403–409.

Published In

Oncologist

DOI

EISSN

1549-490X

Publication Date

April 2018

Volume

23

Issue

4

Start / End Page

403 / 409

Location

England

Related Subject Headings

  • Treatment Outcome
  • Safety
  • Oncology & Carcinogenesis
  • Neutropenia
  • Neoplasm Staging
  • Neoadjuvant Therapy
  • Middle Aged
  • Humans
  • Hematologic Agents
  • Filgrastim