Zentiva Enters Biologics Market with Launch of First Biosimilar Across the EU

Zentiva Takes a Bold Step into the Biosimilars Market

On December 1, 2025, Zentiva, a prominent European producer specializing in affordable, high-quality pharmaceuticals, made a significant stride by launching its first monoclonal antibody biosimilar throughout the European Union. This move followed the approval from the European Medicines Agency (EMA) and marks a crucial development in Zentiva's mission to enhance patient access to essential healthcare.

CEO Steffen Saltofte remarked on the importance of this launch, describing it as a pivotal moment for the company. He emphasized that venturing into biological medicines aligns perfectly with Zentiva's goal of making high-quality treatments accessible and inexpensive for patients across Europe. This new trajectory not only broadens the company’s reach but also sets the stage for sustainable growth in a rapidly evolving segment of the pharmaceutical arena.

The biosimilar introduced by Zentiva is a monoclonal antibody aimed at treating various bone conditions. With the EMA's centralized procedure for authorization, it will gradually be introduced into markets through December, reflecting the company's strategic approach to distribution and accessibility.

This foray into biosimilars represents a significant element of Zentiva's overarching growth strategy, which aims to diversify its offerings beyond traditional generic medicines. With biologic drugs increasingly claiming a larger share of healthcare expenditures in Europe, the establishment of a strong biosimilar portfolio is essential for both the sustainability of healthcare systems and the accessibility of modern therapies for patients.

About Zentiva

Zentiva is dedicated to promoting health and well-being for all demographics, with its operations impacting over 100 million individuals in more than 30 nations across Europe. The company focuses on the development, production, and distribution of high-quality, cost-effective medicines. Featuring four wholly-owned manufacturing facilities and a robust network of external partners, Zentiva ensures secure supply channels for its products. Committed to sustainable growth, Zentiva employs over 5,000 talents unified by their dedication to the well-being of those who rely on their medications daily. The future for Zentiva appears promising with ambitious plans slated for the next few years. For more information about their initiatives, visit www.zentiva.com.