Sandoz has announced the launch of its generic paclitaxel protein-bound particles for injectable suspension (albumin-bound), a development poised to expand access to a crucial treatment for metastatic breast cancer. This formulation marks the first FDA-approved Abbreviated New Drug Application (ANDA) referencing BioScience’s Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound).
The newly available generic paclitaxel is indicated for the treatment of metastatic breast cancer in adult patients. The drug is presented as a lyophilized powder for injection, containing 100 mg of paclitaxel in a single-dose vial designed for intravenous administration. The FDA granted approval for this product on October 8, 2024.
Keren Haruvi, President of Sandoz North America, emphasized the significance of this launch, stating, “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.”
Development Partnership
The generic paclitaxel formulation was developed through a partnership between Sandoz and Jiangsu Hengrui Pharmaceuticals, leveraging their combined expertise to bring this critical medication to market.
Metastatic Breast Cancer Treatment Landscape
Metastatic breast cancer represents a significant challenge in oncology, requiring ongoing treatment to manage disease progression and improve patient outcomes. Paclitaxel, a taxane chemotherapy drug, plays a vital role in various treatment regimens. The introduction of a generic option by Sandoz aims to provide a more cost-effective alternative, potentially easing the financial burden on patients and healthcare systems.
