ABP 980 (KANJINTI™) is a biosimilar to trastuzumab reference product (RP).

It is highly similar to the RP in analytical characteristics and, like the RP, binds with high affinity to human epidermal growth factor receptor-2 (HER2), blocking its activation and inhibiting the proliferation of HER2-expressing cells.

The pharmacokinetics and pharmacodynamics of ABP 980 are also highly similar to those of trastuzumab RP; in a healthy volunteer equivalence study, the geometric mean ratios and 90% confidence intervals of key PK parameters—AUC0-inf and Cmax—for the two products fell within the equivalence criteria of 0.80–1.25.

A comparative clinical trial in patients with early breast cancer has shown similar pathologic complete response with ABP 980 versus RP, with no new safety or immunologic concerns.

Like the RP, ABP 980 product is supplied as a lyophilized powder that should be reconstituted and diluted prior to use as intravenous infusion.

The totality of evidence showed that ABP 980 is highly similar to trastuzumab RP, with no clinically meaningful differences, thus supporting extrapolation to all approved indications of the RP and providing an alternative to trastuzumab RP in the treatment of patients with breast and gastric cancers.