Global pharmaceutical major Lupin Limited has entered into a strategic license and supply agreement with Zentiva Group, a prominent pan-European pharmaceutical company, to bring its biosimilar Certolizumab Pegol to patients across key global markets.

Under the agreement, Lupin will handle the development, manufacturing, and supply of the biosimilar, while Zentiva will spearhead commercialization efforts outside the United States and Canada, particularly in Europe and the Commonwealth of Independent States (CIS). Lupin will manage commercialization in the remaining territories, including the U.S. and Canadian markets.

The collaboration is aimed at accelerating access to affordable, high-quality biosimilar therapies, particularly for patients suffering from chronic inflammatory diseases. Certolizumab Pegol is approved for the treatment of multiple conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis, moderate-to-severe plaque psoriasis, and Crohn’s disease.

Lupin is set to receive an initial payment of USD 10 million upon execution of the agreement and may earn up to USD 50 million in development and regulatory milestone payments. The two companies will also share profits from the defined markets as per the agreement.

“This 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,” said Fabrice Egros, President of Corporate Development at Lupin. “This partnership underscores our dedication to improving the quality of life for individuals living with chronic conditions and ensuring accessibility and affordability of transformative therapies worldwide.”

Certolizumab Pegol is a recombinant, humanized antibody Fab' fragment that targets tumor necrosis factor alpha (TNFα), a key player in inflammatory diseases. Its biosimilar version is expected to make a significant impact by reducing treatment costs and expanding patient access, particularly in markets where biologics remain out of reach for many.

The alliance marks a significant step in Lupin’s ongoing efforts to strengthen its global biosimilar portfolio and expand its footprint in regulated markets.