PF PRISM C.V.

Alembic Pharmaceuticals Receives FDA Tentative Approval for 400mg Bosutinib Cancer Treatment

- Alembic Pharmaceuticals secured tentative FDA approval for its 400mg Bosutinib tablets, a kinase inhibitor used to treat Philadelphia chromosome-positive chronic myelogenous leukemia. - The approved product is therapeutically equivalent to Bosulif tablets marketed by PF Prism C.V., with an estimated US market size of $251 million for the twelve months ending September 2025. - This approval adds to Alembic's existing final FDA approvals for 100mg and 500mg Bosutinib tablets, bringing the company's total ANDA approvals to 232. - Bosutinib is indicated for adult patients with chronic phase Ph+ CML, including newly-diagnosed cases and those resistant or intolerant to prior therapies.