Zentiva and Lupin Forge Strategic Alliance for Biosimilar TNF-alpha Inhibitor
Zentiva and Lupin Join Forces for Healthcare Accessibility
In a significant development in the pharmaceutical industry, Zentiva Group and Lupin Limited have entered a strategic partnership focused on promoting the availability of a biosimilar TNF-alpha inhibitor. This alliance is intended to accelerate the introduction of high-quality and affordable biologic medicines for patients across multiple markets globally, primarily targeting regions outside the United States and Canada, including Europe and the CIS countries.
License and Supply Agreement
On July 10, 2025, both companies announced that they have signed a comprehensive licensing and supply agreement aimed at the marketing of Lupin’s biosimilar TNF-alpha inhibitor. Under the terms of this deal, Zentiva will spearhead marketing initiatives in designated territories, leveraging its extensive European distribution network and regulatory expertise. Meanwhile, Lupin will oversee the development, manufacturing, and supply of the product in these specified markets and will retain marketing rights in the US and Canadian regions.
This collaborative effort reflects a shared commitment to advancing patient access to essential therapies, especially in areas where high treatment costs can be barriers to care. Steffen Saltofte, the CEO of Zentiva, expressed optimism about this partnership, stating that it signifies an important step in ensuring affordable quality healthcare for all.
Investment and Financial Framework
As part of this agreement, Lupin will receive an initial payment of $10 million, along with milestone payments that could total up to $50 million, contingent upon successful development and regulatory approval of the biosimilar product. The financial returns from agreed markets will be shared between Zentiva and Lupin, further entwining their financial fates and reinforcing their collaborative efforts.
Product Details and Market Impact
The biosimilar in question features a recombinant, humanized Fab’ fragment designed to inhibit tumor necrosis factor alpha (TNFα). It is indicated for the treatment of various autoimmune conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis arthritis, non-radiographic axial spondyloarthritis, moderate-to-severe plaque psoriasis, and Crohn’s disease. By providing a more affordable alternative to existing therapies, this product is poised to significantly enhance treatment accessibility for many patients.
In the words of Saltofte, "The collaboration with Lupin embodies our commitment to facilitating access to high-quality healthcare solutions as part of our biosimilars strategy. With Lupin's advanced development capabilities paired with our market knowledge, we are poised to deliver substantial benefits to patients relying on our medications."
About Zentiva
Founded on the principle of promoting health and well-being for all generations, Zentiva focuses on the development, manufacturing, and distribution of high-quality, affordable medications. With a presence in over 30 countries and a dedication to serving more than 100 million individuals, Zentiva operates four manufacturing sites and collaborates with a broad network of external partners to ensure supply security. The company’s investment in over 5,000 dedicated personnel exemplifies its relentless commitment to providing necessary healthcare solutions.
As the demand for affordable therapies increases, this collaboration between Zentiva and Lupin not only emphasizes the importance of strategic partnerships in healthcare but also sets a precedent for future collaborations aimed at enhancing global access to essential medications.