Lupin and Zentiva Forge Strategic Partnership for Global Commercialization of Certolizumab Pegol Biosimilar

Lupin Limited, a global pharmaceutical leader, and Zentiva Group, a prominent pan-European pharmaceutical company, announced a landmark license and supply agreement to commercialize Lupin’s biosimilar Certolizumab Pegol across multiple global markets.

This strategic collaboration is designed to expedite the availability of a high-quality, cost-effective biosimilar Certolizumab Pegol to patients worldwide. Lupin will take charge of the product’s development, manufacturing, and supply within the designated territories. Zentiva will handle commercialization efforts outside the USA and Canada, focusing primarily on Europe and CIS markets, utilizing its robust European commercial network and regulatory expertise. Lupin will manage commercialization in the remaining regions, including the USA and Canada.

Both companies are committed to investing in the development of this new biosimilar. Lupin will receive an initial payment of $10 million upon signing the agreement, with potential development and regulatory milestone payments totaling up to $50 million. Profits from the specified markets will be shared between the two partners.

Certolizumab Pegol is a recombinant, humanized antibody Fab’ fragment specifically targeting human tumor necrosis factor alpha (TNFα), conjugated to an approximately 40kDa polyethylene glycol. It is approved for treating rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis, moderate-to-severe plaque psoriasis, and Crohn’s disease.

Fabrice Egros, President of Corporate Development at Lupin, emphasized the significance of this partnership, stating, “Our global development and commercialization alliance with Zentiva, with its pan-European focus, enables Lupin to bring this unique biosimilar to its core markets and through Zentiva in Europe. This partnership reflects our commitment to enhancing the quality of life for individuals with chronic conditions by ensuring access to affordable, transformative therapies worldwide.”