Lupin Limited, a leading global pharmaceutical company headquartered in Mumbai, India, has announced a strategic partnership with Zentiva Group, a major pan-European pharmaceutical company, to commercialize Lupin’s biosimilar Certolizumab Pegol across multiple markets worldwide.

This agreement marks a significant milestone for both companies as they seek to expand access to high-quality, cost-effective biosimilars for patients dealing with chronic autoimmune conditions.

Strategic Importance of the Agreement

The license and supply agreement enables Lupin to leverage Zentiva’s well-established commercial infrastructure and regulatory expertise across Europe and the Commonwealth of Independent States (CIS) markets.

Under this partnership, Lupin will retain responsibility for development, manufacturing, and supply of Certolizumab Pegol, while Zentiva will oversee commercialization in its designated territories, predominantly in Europe and CIS.

Lupin will handle commercialization activities for the USA, Canada, and other regions, reinforcing its global strategy to penetrate key pharmaceutical markets while maximising operational efficiencies through strategic alliances.

Financial Structure and Payment Terms

As part of the agreement, Lupin will receive an initial payment of USD 10 million upon execution of the deal. The agreement also includes total development and regulatory milestone payments of up to USD 50 million.

Profits generated from the defined markets will be shared between the two companies, ensuring a mutually beneficial financial structure that aligns incentives and promotes long-term collaboration.

This revenue-sharing model reflects a modern approach to pharmaceutical partnerships, where risks and rewards are distributed fairly, encouraging both parties to invest in market development and patient access.

About Certolizumab Pegol

Certolizumab Pegol is a recombinant, humanized antibody Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα), a cytokine involved in systemic inflammation.

It is conjugated to an approximately 40kDa polyethylene glycol (PEG) molecule to extend its half-life and reduce immunogenicity.

This biosimilar is indicated for the treatment of multiple chronic inflammatory conditions, including:

• Rheumatoid arthritis

• Polyarticular juvenile idiopathic arthritis

• Psoriatic arthritis

• Non-radiographic axial spondyloarthritis

• Moderate-to-severe plaque psoriasis

• Crohn’s disease

These diseases are debilitating and often require long-term management, making biosimilars critical in ensuring affordable access to effective therapies for millions of patients worldwide.

Addressing Global Healthcare Needs

The launch of Lupin’s biosimilar Certolizumab Pegol aims to address the growing demand for cost-effective biologics across global markets.

Biosimilars are highly similar to approved reference biologic products but are typically priced significantly lower, making them a key strategy for healthcare systems aiming to manage rising drug costs without compromising treatment quality.

With healthcare budgets under pressure, particularly in emerging markets, increasing access to affordable biosimilars is essential for achieving sustainable healthcare outcomes.

Lupin has been investing heavily in its biosimilars pipeline, viewing these products as central to its long-term growth strategy and commitment to patient well-being.

Lupin’s Global Development and Manufacturing Expertise

Under the terms of the agreement, Lupin will retain full responsibility for the development, manufacturing, and supply of Certolizumab Pegol.

Lupin has built a strong reputation for manufacturing excellence, with 15 state-of-the-art manufacturing sites and 7 research centers worldwide.

The company employs over 23,000 professionals, including highly skilled scientists, engineers, and regulatory experts dedicated to ensuring quality, compliance, and innovation.

Fabrice Egros, President of Corporate Development at Lupin, emphasised that this partnership underscores Lupin’s dedication to improving the quality of life for patients worldwide while ensuring accessibility and affordability of transformative therapies.

“Our global development and commercialization partnership with Zentiva, with its pan-European focus, enables Lupin to commercialize this unique biosimilar in its core markets and through Zentiva in Europe,” he said.

Zentiva’s Commercial Strength in Europe

Zentiva Group brings significant commercial and regulatory expertise in the European market, with an extensive network of marketing and distribution channels.

Zentiva’s deep understanding of the regulatory landscape across Europe and the CIS is expected to accelerate market entry for Certolizumab Pegol, providing patients with earlier access to a much-needed therapy.

This partnership demonstrates Zentiva’s commitment to expanding its biosimilars portfolio and offering affordable treatment options for chronic diseases.

Zentiva’s existing commercial infrastructure ensures that the biosimilar can be efficiently marketed and distributed across multiple countries, minimising time to market and optimising patient reach.

The Biosimilars Market Opportunity

The global biosimilars market has seen explosive growth over the past decade, driven by the patent expiry of major biologic drugs and the need for more cost-effective therapies.

Biologics account for a significant portion of global pharmaceutical spending, often representing the largest cost burden for healthcare systems.

By offering high-quality, affordable alternatives, biosimilars can deliver substantial savings while expanding access for patients who might otherwise be unable to afford treatment.

Analysts predict that the biosimilars market will continue to expand rapidly, with oncology, autoimmune diseases, and endocrinology among the fastest-growing therapy areas.

Certolizumab Pegol, as a treatment for chronic inflammatory diseases, is well-positioned to capture strong demand in both developed and emerging markets.

Lupin’s Broader Pharmaceutical Portfolio

Lupin Limited is a global pharmaceutical leader, trusted by healthcare professionals and patients across over 100 markets.

The company specialises in a wide range of products, including:

• Branded and generic formulations

• Complex generics

• Biotechnology products

• Active pharmaceutical ingredients (APIs)

Lupin’s diversified portfolio ensures resilience against market fluctuations and positions the company as a key partner for global healthcare systems.

The company enjoys a strong presence in India and the U.S., with established leadership in multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.

Beyond pharmaceuticals, Lupin is committed to improving patient health outcomes through subsidiaries like Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Commitment to Research and Innovation

Lupin continues to invest in research and development (R&D) to ensure a pipeline of innovative and affordable medicines.

With 7 global research centers, the company is focused on:

• Developing new generics and complex generics

• Expanding its biosimilars portfolio

• Innovating in digital health solutions

• Improving manufacturing technologies

This focus on innovation enables Lupin to maintain its competitive edge while fulfilling its mission of improving health outcomes for patients around the world.

Conclusion

The license and supply agreement between Lupin and Zentiva represents a significant step forward in the global effort to increase access to affordable biosimilars.

By combining Lupin’s expertise in development and manufacturing with Zentiva’s strong commercial presence in Europe and CIS markets, the partnership promises to accelerate availability of Certolizumab Pegol for patients in need.

With mutually beneficial financial terms, including milestone payments and profit sharing, both companies are well-positioned to capitalise on the growing demand for biosimilars while delivering value to healthcare systems and patients worldwide.

This strategic alliance highlights Lupin’s commitment to innovation, accessibility, and patient-centric care, reinforcing its reputation as a trusted partner in the global pharmaceutical industry.

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