Lupin Limited , a leading global pharmaceutical company, has announced a significant licensing agreement for a ranibizumab biosimilar, marking a strategic expansion into the biosimilar medications market. This move underscores Lupin's commitment to broadening its product portfolio and strengthening its position in the ophthalmology sector.

Ranibizumab Biosimilar: A Strategic Addition

Ranibizumab, primarily used in ophthalmology treatments, is a key addition to Lupin's growing biosimilar pipeline. This licensing agreement represents a crucial step in the company's strategy to diversify its product offerings and tap into the lucrative biosimilar market.

Expanding Biosimilar Portfolio

During a recent earnings call, Vinita Gupta, CEO of Lupin Limited, highlighted the company's growing focus on biosimilars:

"Biosimilars is emerging as a platform that is going to have relevance for us in U.S, other developed markets like Europe, Canada, Australia, as well as India. So, a global platform that is really promising," Gupta stated.

The company's biosimilar strategy includes:

1. Pegfilgrastim and its on-body injector version
2. Ophthalmic products like Ranibizumab and Aflibercept
3. Etanercept, expected to launch in FY29
4. Respiratory biosimilars such as Mepolizumab and Benralizumab
5. Oncology and immuno-oncology products for the Indian market

Market Access and Regulatory Environment

Lupin's management expressed optimism about the evolving biosimilar market, particularly in the United States. Gupta noted, "You're just seeing a substantial kind of easing on market access in the last 6-12 months, with Humira and the private labels that have come into market, like the Cordavis label, the Quallent label."

This improved market access, coupled with easing regulatory requirements, is expected to accelerate the company's biosimilar plans.

Strategic Partnerships and Global Reach

Lupin is leveraging strategic partnerships to enhance its biosimilar presence globally. The company recently announced an agreement with Zentiva for biosimilar distribution in Europe, demonstrating its commitment to expanding its reach in key markets.

Financial Implications and Future Outlook

While specific financial details of the ranibizumab licensing deal were not disclosed, Lupin's management expressed confidence in the growth potential of their biosimilar portfolio. The company expects biosimilars to be significant drivers of growth in the coming years, particularly in FY27 and beyond.

Ramesh Swaminathan, Executive Director and Global CFO of Lupin, stated during the earnings call, "We're pretty optimistic about this. The fact is we are playing for continuous margin expansion."

Conclusion

Lupin's licensing agreement for the ranibizumab biosimilar marks a significant milestone in the company's expansion into the biosimilar market. With a robust pipeline and strategic focus on complex products, Lupin is well-positioned to capitalize on the growing opportunities in the global biosimilar landscape. As the company continues to invest in research and development and forge strategic partnerships, it aims to establish itself as a key player in the biosimilar segment, driving long-term growth and value creation for stakeholders.

Lupin Limited , a global pharmaceutical leader, has announced the launch of Glucagon for Injection USP, 1mg/vial packaged in an emergency kit in the United States. This launch comes on the heels of the company reporting robust financial results for the first quarter of fiscal year 2026, marking a strong start to the year.

Glucagon Launch in the U.S.

Lupin's Glucagon for Injection USP is bioequivalent to Eli Lilly and Company's Glucagon for Injection. The product is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. It also serves as a diagnostic aid during radiologic examinations to temporarily inhibit gastrointestinal tract movement in adult patients.

The launch of Glucagon for Injection USP represents a significant opportunity for Lupin, with the product having an estimated annual sale of USD 122.00 million in the U.S. market, according to IQVIA MAT June 2025 data.

Strong Q1 FY2026 Performance

Lupin reported impressive financial results for Q1 FY2026:

• Revenue reached INR 6,164.00 crores, up 11.8% year-over-year
• EBITDA increased by 27.6% to INR 1,641.00 crores
• EBITDA margins improved to 26.6%, up 330 basis points from the previous year

Key Business Highlights

U.S. Business Growth

The U.S. business recorded sales of USD 282.00 million, growing 22.3% year-over-year. This growth was primarily driven by the successful launch of Tolvaptan with sole first-to-file exclusivity.

India Business Performance

The India region business grew by 7.8% year-over-year, with the prescription business expanding by 8.6%. Key therapeutic areas like Cardiovascular, Gastrointestinal, and Vitamins, Minerals, and Supplements (VMS) outperformed the Indian Pharmaceutical Market (IPM) growth.

Other Markets

Other Developed Markets, including Europe, saw a 17% year-over-year increase in revenues, with Europe alone growing by 28%. The Global Institution Business (GIB) also showed strong performance, growing by 16% year-over-year.

Strategic Developments and Future Outlook

Lupin has made significant strides in expanding its complex generics portfolio, particularly in injectables, respiratory products, and biosimilars. The company received FDA approvals for generic Victoza and Glucagon, with Glucagon already launched and Liraglutide planned for October launch.

The management expects strong double-digit growth for FY2026, with EBITDA margin guidance of 24-25%. However, the company faces competitive pressures from new generic competition in Albuterol and potential additional competition for Tolvaptan.

Vinita Gupta, CEO of Lupin Limited, expressed optimism about the company's growth prospects, stating, "We are very optimistic that we continue our growth momentum this fiscal year as well as in the next couple of years despite the challenges on additional competition on key products. We believe that we have significant growth drivers in place."

As Lupin continues to focus on complex generics and specialty products, with nearly 70% of its R&D investments directed towards these areas, the company appears well-positioned for sustained growth in the coming years.