Lupin Limited (Lupin) and Zentiva Group (Zentiva), a pan-European pharmaceutical company, have entered into a license and supply agreement for commercialization of Lupin’s biosimilar Certolizumab Pegol, across multiple markets globally.

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

Lupin will be responsible for the development, manufacturing and supply of the product within the agreed territories. 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 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 US$ 10 million upon execution of the agreement and total development and regulatory milestone payments up to US$ 50 million.  The profits from the defined markets will be shared between the two companies.

Certolizumab Pegol 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.

“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,” said Fabrice Egros, President of Corporate Development, 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."