India Pharma Outlook Team | Wednesday, 14 January 2026
Alembic Pharmaceuticals has clinched tentative approval from the US Food & Drug Administration (USFDA) for its Bosutinib Tablets, 400?mg — a major generic cancer drug move that expands its foothold in the lucrative US oncology market.
The generic version is approved under a supplemental Abbreviated New Drug Application (sANDA) and is considered therapeutically equivalent to the brand-name Bosulif, marketed by PF Prism C.V., for treating certain forms of chronic myelogenous leukemia (CML).
Bosutinib is a targeted kinase inhibitor used to treat adult patients with Philadelphia chromosome-positive (Ph+) CML, including those newly diagnosed, resistant, or intolerant to prior therapies.
Also Read: Advancing Interventional Radiology in India Through Collaboration
The drug also covers accelerated and blast phases of Ph+ CML, addressing a critical need for effective treatment options in hematologic oncology. This tentative nod underscores Alembic’s strategy of strengthening its US generic oncology portfolio.
The company had earlier secured final approvals for Bosutinib in 100?mg and 500?mg strengths. Adding the 400?mg dosage broadens its offering in a segment with an estimated US market size of about $251?million for the year ending September?2025, according to IQVIA data.
For Alembic, a firm with a long track record of global generic entries and strong regulatory experience, this latest approval adds to its growing list of USFDA nods, boosting its total ANDA approvals. While tentative approval means final commercialization depends on patent and exclusivity clearances, this development reinforces Alembic’s commitment to competitive oncology generics and expands patient access to more affordable treatment alternatives in the world’s largest pharmaceutical market.
.jpg)
.jpg)
