Amneal Pharmaceuticals and Shilpa Medicare have launched the new presentation of bortezomib, Boruzu, for subcutaneous or intravenous administration, offering a ready-to-use option for patients with multiple myeloma and mantle cell lymphoma in the US.
Boruzu is the first ready-to-use bortezomib injection for multiple myeloma and mantle cell lymphoma, and lowers the compounding preparation process needed for administration.
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A proteasome inhibitor, Boruzu references branded Velcade, a lyophilised powder that needs reconstitution before usage.
Shilpa has created the molecule, while Amneal will handle the manufacturing and commercialisation of the product.
The most commonly reported adverse events for Boruzu in clinical studies have been anaemia, anorexia, asthenic conditions, diarrhoea, euralgia, gastrointestinal issues, leukopenia, neutropenia, peripheral neuropathy, psychiatric disorders, pyrexia, reduced appetite and thrombocytopenia.
Amneal pharmaceutical biosimilars and branded oncology senior vice-president Sean McGowan stated: “As we advance our broader strategy to build a leading injectables portfolio with durable, high-impact complex products, we are excited to announce the US launch of Boruzu in our oncology portfolio.
“This ready-to-use injectable marks a significant innovation for our customers by streamlining pharmacy preparation steps for clinicians while now carrying a unique J-code to facilitate reimbursement.”
Amneal is a biopharmaceutical company based in Bridgewater, US.
Through its affordable medicines segment, the company focuses on widening complex product categories as well as therapeutic areas, which include biosimilars and injectables.
In its speciality segment, Amneal has a branded pharmaceutical portfolio focusing mainly on endocrine and central nervous system disorders.
The company distributes pharmaceuticals and other products to the federal government of the US, as well as to institutional and retail markets, via its AvKARE segment.
An integrated pharmaceutical group, Shilpa has business interests in peptides, oncology and non-oncology active pharmaceutical ingredients, differentiated finished dosage formulations and polymers.
It also offers contract development and manufacturing organisation services to pharmaceutical firms, supported by research and development and manufacturing capabilities.
In August 2024, the US Food and Drug Administration (FDA) approved Amneal’s Crexont extended-release capsules for treating Parkinson’s disease.
