Zentiva to commercialise Lupin’s biosimilar Certolizumab Pegol, across multiple markets globally
Lupin and Zentiva Group (Zentiva), a pan-European pharmaceutical company, have entered into a license and supply agreement for the commercialisation of Lupin’s biosimilar Certolizumab Pegol, across multiple markets globally.
The 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 commercialisation activities outside the US and Canada, predominantly in Europe and CIS markets, where it will leverage its extensive European commercial infrastructure and regulatory expertise. Lupin will undertake commercialisation in the remaining regions, including the US and Canada.
Both parties will invest in the development of the new biosimilar. Lupin will receive an initial payment of $10 million upon execution of the agreement and total development and regulatory milestone payments up to $50 million. The profits from the defined markets will be shared between the two companies.
Certolizumab Pegol is a recombinant, humanised antibody Fab’ fragment, with specificity for human tumour 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 commercialisation partnership with Zentiva, with its pan-European focus, enables Lupin to commercialise 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.”
