#Zentiva #Czech Republic #Prague #Biosimilar #Lupin

Zentiva and Lupin Collaborate on Biosimilar Development

The pharmaceutical landscape is witnessing a significant shift with the recent announcement of a partnership between Zentiva Group and Lupin Limited, aimed at commercializing a biosimilar medicine targeting TNF alpha inhibition. This collaboration marks an important milestone in the realm of affordable healthcare, benefitting patients globally.

Strategic Importance of the Agreement

The agreement was officially concluded on July 9, 2025, and it encompasses a licensing and supply arrangement specifically for Lupin’s biosimilar product. This initiative reflects both companies' commitment to delivering high-quality and cost-effective treatment options to patients suffering from various autoimmune conditions.

Zentiva will oversee the marketing operations outside of the United States and Canada, focusing primarily on European markets and the Commonwealth of Independent States (CIS). Leveraging its expansive European commercial infrastructure and regulatory expertise, Zentiva aims to enhance patient access to this innovative therapy. Meanwhile, Lupin will manage the development, manufacturing, and supply of the product in the agreed territories and will spearhead marketing efforts in the US and Canada.

Financial Details

As part of the strategic partnership, Lupin is set to receive an initial payment of $10 million at the agreement's signing, with potential milestone payments escalating to a total of $50 million to support development and regulatory processes. The profits generated from sales in the defined markets will be shared between the two companies, signifying a mutual interest in the success of this biosimilar.

Product Overview

The biosimilar in question is a recombinant humanized antibody fragment that specifically targets human TNF alpha. This advanced medication is indicated for treating several conditions, including:

• - Rheumatoid arthritis
• - Juvenile idiopathic arthritis
• - Psoriatic arthritis
• - Non-radiographic axial spondyloarthritis
• - Moderate to severe plaque psoriasis
• - Crohn's disease

Such a broad range of therapeutic indications underscores the significance of this biosimilar, which has the potential to improve quality of life for patients affected by these chronic conditions.

Commitment to Quality Healthcare

In a statement regarding the collaboration, Steffen Saltofte, CEO of Zentiva, emphasized the company’s dedication to ensuring access to quality and affordable healthcare. He stated, “Our partnership with Lupin signifies a significant step forward in our biosimilar product strategies and growth. The advanced development and manufacturing capabilities of Lupin, combined with our market knowledge and substantial presence, will allow us to provide high-quality biosimilar solutions to our customers and their patients.”

This commitment to enhancing patient care reflects Zentiva's broader mission of serving the health and well-being of diverse populations across more than 30 countries.

About Zentiva

Zentiva is dedicated to providing quality medicines that significantly enhance healthcare accessibility. With over 100 million patients relying on its products, the company operates four wholly-owned manufacturing sites and maintains an extensive network of external production partners. As a privately-held entity, Zentiva continues to experience sustainable growth, underpinned by a robust strategic plan for the years ahead.

Through this partnership with Lupin, Zentiva is poised to make significant strides in making biosimilar treatments widely available, ensuring that patients receive the best possible care.