Zydus Lifesciences gets USFDA's nod to market generic version of Bortezomib

Zydus Lifesciences Ltd on Tuesday said it has received the final approval from the US health regulator to market its generic version of Bortezomib for injection used to treat certain types of cancer. The approval by the US Food and Drug Administration (USFDA) is for single-dose vial of Bortezomib for injection of strength 3.5 mg/vial, the company said in a regulatory filing.

The drug, a generic version of reference listed drug Velcade, will be manufactured at Zydus Hospira, Gujarat.

Bortezomib for injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma. The medication works by slowing or stopping the growth of cancer cells, it said.


Citing IQVIA MAT March 2022 data, the company said Velcade has a market size of USD 1.172 billion.

The group now has 331 approvals and has so far filed over 400 ANDAs (abbreviated new drug applications) since the commencement of filing process in FY 2003-04, the filing said.