Pharmaceutical major Lupin Ltd has announced a licensing and supply agreement with the Zentiva Group for the global commercialization of its biosimilar Certolizumab Pegol, with the deal including potential milestone payments of up to USD 50 million.
The partnership aims to speed up the availability of this cost-effective, high-quality biosimilar for patients worldwide, Lupin stated in a regulatory filing on Wednesday.
Under the terms of the agreement, Lupin will handle the development, manufacturing, and supply of Certolizumab Pegol across the specified regions. Zentiva, a leading pan-European pharmaceutical company, will manage commercialization outside the US and Canada — primarily in Europe and the CIS (Commonwealth of Independent States) — utilizing its strong regional infrastructure and regulatory capabilities.
Lupin will retain commercialization rights in other global markets, including the US and Canada.
Both companies will jointly invest in the development of the biosimilar. Lupin will receive an upfront payment of USD 10 million, with additional development and regulatory milestone payments bringing the potential total to USD 50 million. Profits generated from the specified markets will be shared between Lupin and Zentiva.
Certolizumab Pegol is prescribed for a range of autoimmune and inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis, moderate-to-severe plaque psoriasis, and Crohn’s disease.
“This global partnership with Zentiva, especially with its strong pan-European presence, allows us to commercialize this unique biosimilar in key international markets while leveraging Zentiva’s strengths in Europe,” said Fabrice Egros, President of Corporate Development at Lupin.