Zentiva and Lupin Sign License and Supply Agreement for TNF alpha inhibitor biosimilar medicine

PRAGUE, July 9, 2025 /PRNewswire/ -- Zentiva Group and global pharmaceutical company Lupin Limited, have entered into a license and supply agreement for commercialization of Lupin's biosimilar, TNF alpha inhibitor medicine, across multiple markets globally.

This strategic alliance aims to accelerate the availability of high-quality, cost-effective biosimilars to patients worldwide. 

Zentiva will oversee commercialization activities outside USA and Canada, predominantly in Europe and CIS markets, where it will leverage its extensive European commercial infrastructure and regulatory expertise. Lupin will be responsible for the development, manufacturing and supply of the product within the agreed territories. Lupin will undertake commercialization in the remaining regions, including USA and Canada.

Both parties will invest in the development of the new biosimilar. Lupin will receive an initial payment of USD 10 million upon execution of the agreement and total development and regulatory milestone payments up to USD 50 million. The profits from the defined markets will be shared between the two companies.

The biosimilar product is a recombinant, humanized antibody Fab' fragment, with specificity for human tumor necrosis factor alpha (TNFα), conjugated to an approximately 40kDa polyethylene glycol. It is indicated for the treatment of patients with rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis, moderate-to-severe plaque psoriasis and Crohn's disease.

Commenting on the strategic partnership, Steffen Saltofte, Chief Executive Officer, Zentiva, said, "Ensuring accessibility to high-quality and affordable healthcare is at Zentiva's core. Our collaboration agreement with Lupin signifies another step forward in our biosimilars and growth strategies. Lupin's advanced development and manufacturing capabilities coupled with our significant market knowledge and presence means we can deliver high-quality biosimilar solutions for our customers and their patients, aligning with our purpose of providing health and wellbeing for all generations."

About Zentiva

Zentiva provides health and wellbeing for all generations, with a focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 30 countries across Europe and beyond. Zentiva has four wholly-owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. Zentiva employs more than 5,000 unique talents, bonded together by a commitment to the people who depend on our medicines every day. Zentiva is private equity-owned, delivering sustainable growth, with an ambitious plan for the years to come.

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