Trastuzumab Biosimilar Demonstrates Equivalence

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials.

According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete response (bpCR) that was similar to trastuzumab.  Safety outcomes were additionally comparable, with the SB3 group showing a similar rate of treatment-emergent adverse effects as the trastuzumab group.

SB3 has not yet been approved by the FDA, but as previously reported in Big Molecule Watch, the BLA was accepted for review in December 2017.