Biocon Limited , through its wholly owned subsidiary Biocon Pharma Limited, has achieved a significant milestone in its pharmaceutical portfolio. The company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Tofacitinib Extended-Release Tablets.

Approval Details

The FDA has granted final approval for the 11mg strength of Tofacitinib Extended-Release Tablets and tentative approval for the 22mg strength. This development marks a crucial step in Biocon's expansion of its complex drug products portfolio.

Therapeutic Applications

Tofacitinib, classified as a Janus kinase (JAK) inhibitor, is indicated for the treatment of several chronic inflammatory conditions:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Ankylosing Spondylitis
• Ulcerative Colitis

Strategic Importance

The approval of Tofacitinib Extended-Release Tablets is expected to strengthen Biocon's portfolio of vertically integrated, complex drug products. This addition aligns with the company's strategy to expand its presence in the U.S. pharmaceutical market, particularly in the area of chronic disease management.

Market Impact

While specific market share projections were not provided, the approval positions Biocon Pharma to compete in the market for JAK inhibitors. The extended-release formulation could offer patients a convenient dosing option, potentially improving adherence to treatment regimens.

Company Statement

Rajesh U. Shanoy, Company Secretary and Compliance Officer of Biocon Limited, officially communicated this development to the stock exchanges. The company views this approval as a significant step in its ongoing efforts to bring complex, high-quality generic medications to patients in the United States.

Future Outlook

The approval of Tofacitinib Extended-Release Tablets adds to Biocon's growing portfolio of FDA-approved products. As the company continues to invest in research and development, particularly in complex generics and biosimilars, it may see further expansions in its product offerings for the U.S. market.

This latest FDA approval underscores Biocon's commitment to developing and manufacturing complex pharmaceutical products, reinforcing its position in the global generic drug market.

Biocon Limited , a leading biopharmaceutical company, has reported robust financial results for the second quarter of fiscal year 2026, demonstrating significant growth across its key business segments.

Financial Highlights

All financial figures in INR crores

Segment Performance

Biosimilars

• Revenue: INR 2,721.00 crores (25% YoY growth)
• EBITDA: INR 669.00 crores (over 40% growth)
• EBITDA Margin: 25% (up approximately 400 basis points)

Generics

• Revenue: INR 774.00 crores (24% YoY growth)
• R&D Investment: INR 71.00 crores (9% of segment revenues)

CRDMO (Contract Research, Development, and Manufacturing Organization)

• Revenue: INR 911.00 crores (2% YoY growth)
• Reported EBITDA: INR 215.00 crores (23% margin)

Key Developments

1. Debt Reduction: Biocon has strengthened its balance sheet by settling structured debt obligations with Goldman Sachs and Kotak using QIP proceeds. The company expects annual savings of around INR 300.00 crores in interest costs from FY27.

2. Biosimilars Progress:

   • Successful launches of biosimilar Ustekinumab, Aspart, Bevacizumab, and Aflibercept across geographies.
   • U.S. FDA approval for biosimilar Denosumab and a license agreement with Amgen for U.S. commercialization.
   • Strong market traction for Yesintek (biosimilar Ustekinumab) in the U.S., with over 70% commercial formulary coverage.

3. Insulin Partnership: Entered a partnership with the California government through Civica Inc. to supply affordable insulin glargine under the CalRx initiative.

4. ESG Performance: Improved S&P Global Corporate Sustainability Assessment score to 71, up 3 points from the previous year.

5. Generics Expansion: Inaugurated an oral solid dosage manufacturing facility in Cranbury, New Jersey, expanding capacity for the U.S. market.

6. CRDMO Advancements: Syngene secured its first global Phase III clinical trial from a U.S.-based biotech company and expanded its clinical trials footprint globally.

Kiran Mazumdar-Shaw, Executive Chairperson of Biocon, commented on the results, stating, "We've already started to see margin improvement in Q2 following the Goldman Sachs exit, and we expect this trend to continue through quarters 3 and 4 as we see the impact of both Kotak and Edelweiss exits."

Shreehas Tambe, CEO of Biocon Biologics, highlighted the company's strong position in the insulin market, saying, "The only other player outside of that which is a biosimilar insulin player and is in a position to bring in GLP-1s is Biocon. So, it does place us in a very unique position."

Outlook

With a strong pipeline of biosimilars, ongoing expansion in generics, and a growing CRDMO business, Biocon is poised for continued growth. The company's focus on debt reduction and improved profitability is expected to further strengthen its financial position in the coming quarters.