Alembic Pharma Achieves Major Milestone with USFDA Nod for Cancer Treatment

Highlights:-

• Alembic Pharma receives USFDA approval for generic Bosutinib tablets
• Alembic’s version is therapeutically equivalent to Pfizer’s Bosulif
• The approval strengthens Alembic’s global oncology and generics portfolio

The US Food and Drug Administration (USFDA) has granted Alembic Pharmaceuticals final approval for their Abbreviated New Drug Application (ANDA) for bosutinib tablets. Bosulif Tablets, a cancer treatment that was first created and marketed by PF Prism C, can now be sold generically thanks to this regulatory milestone for a Pfizer subsidiary.

Adults with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), whether in the chronic accelerated or blast phase, who have not responded well to previous treatment regimens or who are intolerant of them, are prescribed bosutinib.

With this approval, Alembic offers patients battling this uncommon and complicated form of leukemia a more affordable option, breaking into a crucial market for oncology therapeutics. In order to ensure that the newly approved tablets meet the same quality, safety, and efficacy standards as their branded counterpart, they are regarded as therapeutically equivalent to the reference listed drug.

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The commercial significance of this approval is highlighted by the fact that the Bosutinib market in the United States was valued at about US dollar 291 million for the 12 months ending March 2025, according to data from IQVIA. With this most recent approval, Alembic has now obtained 223 ANDA approvals from the USFDA, including 23 tentative and 200 final approvals, indicating its ongoing growth in the regulated generics market.

As a pharmaceutical company driven by research and development and with a significant presence in international generics markets, Alembic Pharmaceuticals keeps solidifying its position as a vertically integrated business. Leading regulatory bodies such as the USFDA have accredited the company's research and manufacturing facilities, enabling it to provide high-quality, reasonably priced medications to markets in North America, Europe, and other developed regions.

This approval not only broadens Alembic's expanding oncology portfolio but also demonstrates the company's dedication to creating therapies for challenging and urgently needed therapeutic areas. It is a further phase in the company's plan to improve access to essential drugs worldwide by means of innovation, quality, and regulatory excellence.