[Biosimilars in oncology. Focus on SB3 studies.]

Abstract

A phase III study compared SB3, a trastuzumab biosimilar, with trastuzumab originator in 800 HER2 positive breast cancer patients undergoing neoadjuvant chemotherapy. The aim of the study was to demonstrate the equivalence between the two drugs in terms of pathological complete responses. The total pathologic complete response rates were 51.7% and 42.0% with SB3 and trastuzumab, respectively. Equivalence for efficacy was demonstrated between SB3 and trastuzumab. Safety and immunogenicity were comparable.

• Authors: Marzia Del Re, Lucia Del Mastro
• Journal: Recenti progressi in medicina (Recenti Prog Med) Vol. 109 Issue 11 Pg. 531-539 (Nov 2018) ISSN: 2038-1840 [Electronic] Italy
• Vernacular Title: Biosimilari in oncologia. SB3: dagli studi preclinici agli studi clinici.
• PMID: 30565572 (Publication Type: Comparative Study, Journal Article, Review)

Chemical References

• Antineoplastic Agents, Immunological
• Biosimilar Pharmaceuticals
• ERBB2 protein, human
• Receptor, ErbB-2
• Trastuzumab

Topics

• Antineoplastic Agents, Immunological (administration & dosage, adverse effects)
• Biosimilar Pharmaceuticals (administration & dosage, adverse effects)
• Breast Neoplasms (drug therapy)
• Female
• Humans
• Neoadjuvant Therapy (methods)
• Receptor, ErbB-2 (metabolism)
• Trastuzumab (administration & dosage, adverse effects)
• Treatment Outcome