• First FDA-approved abbreviated new drug application (ANDA) to reference medicine
• Single-dose 100 mg vial for intravenous use, approved for metastatic breast cancer
• Launch expected to be near-term growth driver in US market

Sandoz, the global leader in generic and biosimilar medicines, today announced that it has launched a generic paclitaxel formulation in the US, 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) is indicated for the treatment of patients with metastatic breast cancer. The launch of the lyophilized powder for injection containing 100 mg of paclitaxel in a single-dose vial for intravenous use follows approval by the FDA on October 8, 2024.

Keren Haruvi, President, Sandoz North America, said: “An estimated 168,000 women in the US are living with metastatic breast cancer. [1] While rare, men can also develop metastatic breast cancer. [2] This milestone is another proof point of our commitment to provide access to life-changing medicines for all who need them.” 

Sandoz paclitaxel protein-bound particles for injectable suspension (albumin-bound) was developed in partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., and is the first FDA-approved ANDA to reference product Abraxane®* for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound).

*Abraxane® is a registered trademark of Abraxis BioScience LLC, a Bristol-Myers Squibb Company.