Sandoz releases generic Abraxane

Sandoz has launched a generic paclitaxel formulation.

It is the first generic of Abraxis BioScience’s (a Bristol Myers Squibb Co.) Abraxane to be approved by the Food and Drug Administration.

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 Oct. 8.

[Read more: Sandoz receives FDA approval for Prolia, Xgeva biosimilars]

Keren Haruvi, president of Sandoz North America, said, “An estimated 168,000 women in the U.S. are living with metastatic breast cancer. While rare, men can also develop metastatic breast cancer. 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 and is the first FDA-approved ANDA to Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound).

[Read more: Novartis completes Spin-off of Sandoz generics, biosimilars business]