Shares of Alembic Pharmaceuticals may be in focus after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its generic Bosutinib Tablets in 100 mg and 500 mg strengths.
Bosutinib is indicated for the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant or intolerant to prior therapy.
According to IQVIA data, the estimated market size for Bosutinib Tablets in the US stood at USD 291 million for the twelve months ending March 2025.
Alembic stated that the approved product is therapeutically equivalent to Bosulif Tablets, originally marketed by PF Prism C.V. With this latest nod, Alembic has received a cumulative total of 223 ANDA approvals from the USFDA, comprising 200 final approvals and 23 tentative approvals.
This development reinforces Alembic’s commitment to expanding its oncology portfolio in the US generics market.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions.
