Global pharmaceutical company Lupin Limited has entered into a strategic license and supply agreement with Zentiva Group, a leading pan-European pharma firm, to commercialize Lupin’s biosimilar Certolizumab Pegol across multiple global markets.
Accelerating Access to Affordable Therapies
As per the Lupin Press release, this collaboration aims to speed up the global availability of high-quality, cost-effective biosimilar Certolizumab Pegol. The partnership will support broader access to advanced biologic treatment options for patients suffering from chronic inflammatory conditions.
Defined Roles for Development and Commercialization
Under the agreement, Lupin will lead the development, manufacturing, and supply of the biosimilar across the agreed territories. Zentiva, in turn, will manage commercialization activities outside the USA and Canada, focusing mainly on Europe and CIS markets, where it will leverage its robust commercial infrastructure and regulatory expertise. Meanwhile, Lupin will commercialize the product in the USA, Canada, and other remaining markets.
Mutual Investment and Revenue Sharing
Both companies have committed to co-investing in the development of Certolizumab Pegol. Upon signing the agreement, Lupin will receive an initial payment of USD 10 million. Additionally, Lupin is eligible for further development and regulatory milestone payments of up to USD 50 million. Profits from the defined markets will be shared between Lupin and Zentiva.
About Certolizumab Pegol
Certolizumab Pegol is a recombinant, humanized antibody Fab’ fragment targeting tumor necrosis factor alpha (TNFα). It is conjugated to a polyethylene glycol (PEG) molecule to enhance its pharmacokinetic profile. The biosimilar is indicated for treating multiple autoimmune and inflammatory conditions, including:
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Non-radiographic axial spondyloarthritis
- Moderate-to-severe plaque psoriasis
- Crohn’s disease
A Shared Vision for Global Health
Fabrice Egros, President of Corporate Development at Lupin, highlighted the significance of the partnership:
“Our global development and commercialization partnership with Zentiva, with its pan-European focus, enables Lupin to commercialize this unique biosimilar in its core markets and through Zentiva in Europe. This collaboration reflects our commitment to improving the lives of people living with chronic illnesses by ensuring the accessibility and affordability of transformative therapies worldwide.”
This agreement marks a critical step forward in expanding access to advanced biologics in both developed and emerging markets.