Sandoz Launches Generic Paclitaxel Injection to Treat Metastatic Breast Cancer in Single-Dose Vial

Sandoz has launched a generic paclitaxel medication, marking the first FDA-approved generic version to reference its branded counterpart. This formulation, used for metastatic breast cancer treatment, is a lyophilized powder for intravenous injection and is the first generic to Abraxane®. Sandoz's President highlighted the importance of expanding access to life-saving medications. The launch is expected to be a key growth driver in the U.S. market.

The global cancer burden has been on the rise, with breast cancer (BC) being the most common cancer and the leading cause of cancer-related deaths among women [1]. The treatment landscape for BC is complex, with various options available, including surgical resection, radiotherapeutic treatments, endocrine therapies, and chemotherapeutic treatments [12]. Chemotherapy, particularly with paclitaxel (PTX), remains a cornerstone of BC treatment, particularly for metastatic forms of the disease [12, 14].

Sandoz, a Novartis subsidiary, has recently made a significant stride in expanding access to this life-saving treatment by launching the first FDA-approved generic version of paclitaxel for injection [2]. This lyophilized powder for intravenous administration is the first generic version to reference Abraxane®, the branded counterpart used for metastatic BC treatment.

PTX is derived from natural sources and is known for its effectiveness in inhibiting the growth of cancer cells and inducing cell death [13]. Combining PTX with other drugs can further improve its efficacy [13]. The availability of a generic alternative is expected to be a key growth driver in the U.S. market, particularly in light of the increasing burden of cancer and the high cost of branded treatments.

The importance of expanding access to life-saving medications cannot be overstated. According to the American Cancer Society, an estimated 2.3 million new cases of BC and 685,000 deaths were reported worldwide in 2020 [8]. The risk of developing BC is influenced by factors such as age and genetics, with older women and those with a family history of diabetes being at increased risk [9, 10, 11].

The development of new therapies and the availability of generic alternatives are crucial in addressing the complex and evolving nature of cancer. As research continues to uncover new genomic alterations and their effects on cancer cells, the potential for new therapeutic targets and combination strategies becomes increasingly promising [4-6].

References:

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2. Sandoz Announces FDA Approval of First Generic Version of Abraxane® (paclitaxel albumin particulate) Injection, Indicated for the Treatment of Metastatic Breast Cancer. PR Newswire. 2023. https://www.prnewswire.com/news-releases/sandoz-announces-fda-approval-of-first-generic-version-of-abraxane--paclitaxel-albumin-particulate--injection--indicated-for-the-treatment-of-metastatic-breast-cancer-301681879.html
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