Lupin Limited , a global pharmaceutical leader, has announced the launch of Bosentan Tablets for Oral Suspension, 32 mg, in the United States market. This strategic move follows the approval received by Lupin's alliance partner, NATCO Pharma Limited, from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application.

Exclusive First-to-File Status

NATCO Pharma Limited holds the exclusive first-to-file status for this product, granting them a significant 180-day generic drug exclusivity period. This advantage positions Lupin and NATCO favorably in the competitive pharmaceutical market.

Product Details and Indications

The newly launched Bosentan Tablets for Oral Suspension, 32 mg, are bioequivalent to Tracleer® Tablets for Oral Suspension, manufactured by Actelion Pharmaceuticals US, Inc. These tablets are specifically indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older with idiopathic or congenital PAH.

The primary goal of this treatment is to improve pulmonary vascular resistance (PVR), which is expected to result in enhanced exercise ability for patients. This launch addresses a critical need in pediatric PAH treatment, potentially improving the quality of life for young patients suffering from this condition.

Market Potential

According to IQVIA data, Bosentan Tablets (RLD Tracleer®) had estimated annual sales of USD 10.00 million in the U.S. market. This figure underscores the potential market opportunity for Lupin and NATCO with their generic version of the drug.

About Lupin Limited

Lupin Limited, headquartered in Mumbai, India, is a prominent player in the global pharmaceutical industry. The company's products are distributed in over 100 markets worldwide. Lupin specializes in a wide range of pharmaceutical products, including:

• Branded and generic formulations
• Complex generics
• Biotechnology products
• Active pharmaceutical ingredients

With a strong presence in India and the United States, Lupin has established itself as a trusted name among healthcare professionals and consumers across multiple therapy areas, including:

• Respiratory
• Cardiovascular
• Anti-diabetic
• Anti-infective
• Gastrointestinal
• Central nervous system
• Women's health

The company boasts an impressive infrastructure with 15 state-of-the-art manufacturing sites and 7 research centers globally. Lupin's dedicated workforce of over 24,000 professionals contributes to its mission of improving patient health outcomes through various subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

This latest product launch reinforces Lupin's commitment to expanding its portfolio and addressing critical healthcare needs in the U.S. market, particularly in the area of pediatric pulmonary arterial hypertension treatment.

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.