Biosimilars in oncology. Focus on SB3 studies [Biosimilars in oncology. Focus on SB3 studies]

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