FDA Approves Fifth Biosimilar to Herceptin

The Food and Drug Administration (FDA) approved Kanjinti (trastuzumab-anns), a biosimilar to the US-licensed Herceptin (trastuzumab). This marks the fifth approval by the FDA for a Herceptin biosimilar.

Herceptin is indicated for the treatment of human epidermal growth factor receptor 2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The FDA based its approval on new safety data from double-blind, multicenter phase 3 LILAC study that demonstrated that the biosimilar had comparable cardiac safety to the reference product.

In the study, 725 patients with HER2-positive early breast cancer were randomized to receive the biosimilar or the reference Herceptin After four cycles of chemotherapy, patients received a neoadjuvant course of their assigned therapy along with paclitaxel for four cycles. The efficacy analysis was conducted from tissue collected at surgery.

The study’s primary endpoints were risk differences and risk ratio of pathologic complete response in breast tissue and axillary lymph nodes by local laboratory and central pathology evaluation.

By local review, the primary pathologic complete response endpoint was achieved in 48.0% of those randomized to Kanjinti versus 40.5% of those randomized to reference Herceptin. The advantage for the biosimilar exceeded the prespecified 13.0% margin for bioequivalence by risk differences. However, the prespecified margins were not exceeded in the central review.

A biosimilar is a biological product that is demonstrated to be highly similar to an already-approved biological product, and that has no clinically meaningful differences in terms of safety, purity and potency from the reference product.

The approval also marks the 20th biosimilar approved by the FDA.