Mumbai-based global pharmaceutical major Lupin has entered into a license and supply agreement with Czech-based Zentiva Group for the global commercialisation of its biosimilar Certolizumab Pegol.

Under the agreement, Lupin will handle the development, manufacturing, and supply of the biosimilar within the agreed territories.

Zentiva will be responsible for marketing and distribution of the product in markets outside the USA and Canada—primarily across Europe and the CIS (Commonwealth of Independent States) region—leveraging its strong commercial infrastructure and regulatory expertise. Commercialisation in the United States and Canada will be led by Lupin.

Both companies will jointly invest in the biosimilar’s development. Lupin will receive an initial payment of USD 10 million, along with milestone payments of up to USD 50 million. Profits from the defined markets will be shared between the two firms.

 “Our global development and commercialisation 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,” he added.

Steffen Saltofte, CEO of Zentiva, described this agreement as another step forward in their biosimilars and growth strategies.

“Lupin’s advanced development and manufacturing capabilities coupled with our significant market knowledge and presence means we can deliver high-quality biosimilar solutions for our customers and their patients, aligning with our purpose of providing health and wellbeing for all generations,” he said.

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.

In a separate development, Lupin has officially launched Prucalopride Tablets in the United States following approval from the U.S. Food and Drug Administration (FDA).

The tablets are bioequivalent to Takeda’s Motegrity and are indicated for the treatment of chronic idiopathic constipation. This marks Lupin’s entry into the market with a product designed specifically for this gastrointestinal condition.

With the launch, Lupin aims to provide patients with another treatment option while expanding its presence in the U.S. pharmaceutical market.

Lupin operates 15 manufacturing facilities and seven research centres worldwide. Its portfolio includes branded and generic formulations, biosimilars, and APIs, supported by subsidiaries like Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.