Sandoz launches first FDA-approved generic of Abraxane

Swiss generic and biosimilar medicines major Sandoz (SIX: SDZ) today announced that it has launched a generic paclitaxel formulation in the USA, the first generic to its reference medicine to be approved by the US Food and Drug Administration (FDA).

Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) was developed in partnership with Jiangsu Hengrui Pharmaceuticals and is the first FDA-approved abbreviated new drug application (ANDA) to reference product Bristol Myers Squibb’s (NYSE: BMY) Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound). Branded Abraxane generated US sales of $709 million for BMS last year.

Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) is indicated for the treatment of patients with metastatic breast cancer. The launch of the lyophilized powder for injection containing 100mg of paclitaxel in a single-dose vial for intravenous use follows approval by the FDA on October 8, 2024.