Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies

Harbeck, Nadia; Wang, Jessie; Otto, Gordon Philipp; Gattu, Sreekanth und Krendyukov, Andriy (2019): Safety analysis of proposed pegfilgrastim biosimilar in Phase I and Phase III studies. In: Future Oncology, Bd. 15, Nr. 12: S. 1313-1322

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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 1479-6694
• Sprache: Englisch