Lupin, Zentiva Sign Global Pact For Certolizumab Pegol, Biosimilar To Be Commercialised Across Key Markets

New Delhi: Pharma major Lupin Ltd on Wednesday said it has inked a license and supply pact for commercialisation of its biosimilar 'Certolizumab Pegol' across multiple global markets with the Zentiva Group, entailing milestone receivables of up to USD 50 million.

This alliance aims to accelerate the availability of high-quality, cost-effective biosimilar Certolizumab Pegol to patients worldwide, Lupin said in a regulatory filing.

Under the agreement, Lupin will be responsible for the development, manufacturing and supply of the product within the agreed territories.

On the other hand, Zentiva, a pan-European pharmaceutical firm, 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, the company added.

Lupin will undertake commercialisation in the remaining regions, including the US and Canada, it said.

"Both parties will invest in the development of the new biosimilar. Lupin will receive an initial payment of USD 10 million upon execution of the agreement and total development and regulatory milestone payments up to USD 50 million," the Indian pharma major said.

The profits from the defined markets will be shared between the two companies, it added.

Certolizumab Pegol 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," Lupin President of Corporate Development Fabrice Egros said.

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