Zentiva Launches First Biosimilar Monoclonal Antibody Across EU Markets
Key Insights
Zentiva announced the EU-wide launch of its first biosimilar monoclonal antibody following European Medicines Agency approval, marking the company's strategic entry into the biologics market.
The biosimilar targets bone conditions and will be progressively rolled out across European markets starting in December 2025.
This launch represents part of Zentiva's broader diversification strategy beyond traditional generics to improve patient access to affordable biologic medicines across Europe.
Zentiva, a leading European manufacturer of affordable medicines, has announced the EU-wide launch of its first biosimilar monoclonal antibody following approval by the European Medicines Agency (EMA). This milestone marks the company's strategic entry into the biosimilar segment and reinforces its mission to broaden patient access to high-quality biologic medicines across Europe.
The biosimilar monoclonal antibody is indicated for the treatment of bone conditions and has been authorized through the EMA's centralized procedure. Zentiva plans to make the product available progressively across European markets starting in December 2025.
Strategic Expansion into Biologics
"Today's launch is a key moment for Zentiva," said Steffen Saltofte, CEO of Zentiva. "We are taking a significant step into the field of biological medicines. Biosimilars are a natural extension of our mission to make high-quality treatments more accessible and affordable for people across Europe. This expansion also positions Zentiva for sustainable growth in one of the most dynamic segments of the pharmaceutical industry."
The entry into biosimilars forms part of Zentiva's broader strategic growth plan to diversify the company's product offering beyond traditional generics. With biologic medicines representing a growing share of healthcare spending in Europe, biosimilars are positioned as key to ensuring healthcare system sustainability and patient access to modern therapies.
Market Impact and Company Profile
Zentiva provides healthcare solutions to more than 100 million people in over 30 countries across Europe and beyond. The company operates four wholly owned manufacturing sites and maintains a broad network of external manufacturing partners to ensure supply security. With more than 5,000 employees, Zentiva is private equity-owned and focused on delivering sustainable growth with ambitious expansion plans.
This biosimilar launch represents a significant milestone in Zentiva's evolution from a traditional generics manufacturer to a more diversified pharmaceutical company capable of addressing the growing demand for affordable biologic treatments in European healthcare systems.