Zentiva Marks a New Era by Launching Its First Biosimilar Drug in the EU

Zentiva Expands Into the Biosimilar Market

On December 1, 2025, Zentiva, a leading European manufacturer of affordable and high-quality medications, announced a significant milestone: the launch of its first biosimilar monoclonal antibody across the European Union (EU). This strategic move illustrates Zentiva's commitment to improving access to essential treatments for patients throughout Europe.

Steffen Saltofte, Zentiva's CEO, stated, "The launch today is a key moment for Zentiva. We are taking an important step into the field of biologics. Biosimilars are a natural extension of our mission to achieve better accessibility and affordability of high-quality treatments for people across Europe. Additionally, this expansion allows Zentiva to enjoy sustainable growth in one of the most dynamic segments of the pharmaceutical industry."

With the approval granted by the European Medicines Agency (EMA), Zentiva's new biosimilar is set to gradually enter European markets in December, offering treatment options for bone diseases. This strategic entry into the biosimilars segment is part of a broader growth plan aimed at diversifying the company’s product offerings beyond traditional generics. In Europe, biologics comprise an increasing share of healthcare expenditures, making biosimilars crucial for ensuring the sustainability of healthcare systems and the availability of modern treatment options for patients.

Zentiva, which focuses on developing, manufacturing, and delivering high-quality and affordable medications to over 100 million people in more than 30 countries across Europe and beyond, emphasizes the importance of ensuring safe supply chains through its four wholly-owned manufacturing facilities and extensive network of external manufacturing partners. The company employs over 5,000 unique talents committed to providing access to medications that address the needs of patients daily.

This launch not only solidifies Zentiva's position as a trusted healthcare partner but also represents a significant leap toward enhancing patient access to essential medical therapies. The company’s ambition to play a pivotal role in the development of biosimilars showcases its dedication to sustainable growth while fulfilling the healthcare needs of today’s society.

As the pharmaceutical landscape continues to evolve, Zentiva's expansion into the biosimilar market demonstrates the company's responsiveness to emerging healthcare demands and its commitment to providing accessible, high-quality treatment options for patients in Europe.

For more information, visit Zentiva's website.