Aurobindo Pharma arm gets U.S. FDA nod for generic of BMS’ cancer drug

Aurobindo Pharma's Eugia Pharma approved to manufacture Dasatinib Tablets, a bioequivalent to Bristol-Myers Squibb's Sprycel, launching soon.

Aurobindo Pharma subsidiary Eugia Pharma Specialities has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Dasatinib Tablets in different strengths.

Bioequivalent and therapeutically equivalent to the reference listed drug Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company (BMS), the product is expected to be launched by June. The approved product has an estimated market size of $1.8 billion for the twelve months ending February 2025, Aurobindo said, citing IQVIA MAT numbers.

Dasatinib Tablets is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in chronic phase; adults with chronic, accelerated or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy; and adults with Ph+ acute lymphoblastic leukaemia with resistance or intolerance to prior therapy, the company said.

This is the 181st ANDA approval, including nine tentative approvals received, out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oncology oral and sterile specialty products.