Pharmaceutical giant Cipla announced on Friday that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for paclitaxel protein-bound particles for injectable suspension. This injectable formulation is the generic equivalent of Bristol Myers Squibb's Abraxane and will be available in a 100 mg/vial, single-dose format.
The approval represents a significant milestone for Cipla's oncology portfolio expansion in the US market. The company plans to launch this product during the first half of fiscal year 2025-26, ahead of its previously communicated timeline that had indicated a possible approval in the second half of FY26.
Therapeutic Applications
Cipla's generic paclitaxel formulation is an AB-rated therapeutic equivalent of Abraxane, meaning it has demonstrated bioequivalence to the reference listed drug. The medication is indicated for the treatment of:
- Metastatic breast cancer
- Locally advanced or metastatic non-small cell lung cancer (NSCLC)
- Metastatic adenocarcinoma of the pancreas
This approval strengthens Cipla's position in the complex injectables space, particularly for critical cancer treatments where cost-effective alternatives are needed.
Market Impact and Financial Projections
The announcement had an immediate positive effect on Cipla's stock performance, with shares trading 2.73% higher at Rs 1,454.90 on the Bombay Stock Exchange (BSE) following the news.
According to brokerage firm Elara Capital, the approval came as a positive surprise due to its earlier-than-expected timeline. The firm had already factored approximately $20 million in revenue from generic Abraxane in the US for FY26 in their projections. Despite market erosion and competition from 3-4 generic players currently active in the segment, analysts believe Cipla has the potential to generate up to $50 million from this product.
Competitive Landscape
The generic oncology injectable market in the US remains competitive but lucrative. While the overall market size for Abraxane generics has eroded somewhat due to multiple entrants, specialized manufacturing capabilities for complex injectables like protein-bound paclitaxel limit the number of competitors who can successfully enter this space.
Cipla's ability to secure approval for this complex formulation demonstrates the company's growing technical capabilities in developing specialized generic medications.
Recent Financial Performance
The approval comes on the heels of strong financial performance by Cipla. In its December quarter results, the company reported:
- Net profit increase of 49% year-over-year to ₹1,570 crore
- Revenue growth of 7% to ₹7,073 crore
- EBITDA growth of 14% to ₹1,989 crore
- EBITDA margin expansion by 200 basis points to 28%
For the first nine months of the financial year, Cipla's EBITDA margin stood at 26.9%, exceeding the management guidance of 24.5% to 25.5% for the full year.
While US market sales declined slightly by 2% from the previous year to $226 million, the figure still exceeded analyst expectations of $218 million.
Strategic Significance
The approval of generic Abraxane aligns with Cipla's strategic focus on expanding its specialty and complex generics portfolio in the US market. Complex injectables like protein-bound paclitaxel typically face fewer competitors and offer better margin potential compared to conventional oral solid dosage forms.
This development also reinforces Cipla's commitment to increasing access to critical cancer treatments by providing more affordable alternatives to branded medications, potentially benefiting patients requiring these therapies for metastatic breast cancer, lung cancer, and pancreatic cancer.
