Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies. (5th March 2019)

• Record Type: Journal Article
• Authors: Harbeck, Nadia; Wang, Jessie; Otto, Gordon Philipp; Gattu, Sreekanth; Krendyukov, Andriy
• Is Part Of: Future oncology. Volume 15:Number 12(2019)
• Page Start: 1313
• Page End: 1322
• Publication Date: 2019-03-05
• Subjects: bone marrow -- bone pain -- cytokine -- febrile neutropenia -- G-CSF -- granulocyte colony-stimulating factor -- headache -- hematopoiesis -- safety -- TAC chemotherapy; Oncology -- Periodicals; 616.99405
• DOI: 10.2217/fon-2018-0878
• Languages: English
• ISSNs: 1479-6694

Abstract

Aim: This analysis compares safety data for Sandoz proposed biosimilar (LA-EP2006) and reference pegfilgrastim from a Phase I pharmacokinetic/pharmacodynamic study in healthy volunteers (HVs) and two Phase III confirmatory studies in patients with breast cancer (BC; total n = 808).Patients & methods: Baseline characteristics were summarized, and event rates of bone pain and headache calculated.Results: HVs in the Phase I pharmacokinetic/pharmacodynamic study were generally younger, with lower mean body mass index, versus BC patients in PROTECT-1/-2. Bone pain was the most frequent adverse event with similar incidences with reference versus proposed biosimilar in all studies.Conclusion: No differences in adverse events were found between Sandoz proposed biosimilar and reference pegfilgrastim, notwithstanding some differences between HVs and BC patients.