Zentiva has officially launched its first biosimilar monoclonal antibody across European Union markets, marking a significant entry into the biosimilars sector. This strategic move aims to provide high-quality biologic medicines that are more accessible to patients throughout Europe.
On December 1, 2025, the company announced the launch after receiving approval from the European Medicines Agency (EMA). This development underscores Zentiva’s commitment to enhancing the availability of essential treatments, reinforcing its position as a trusted partner in the pharmaceutical industry.
Steffen Saltofte, CEO of Zentiva, commented on the launch, stating, “Today’s official introduction is a pivotal moment for Zentiva. We have taken a substantial step into the realm of biologic medicines. Biosimilars are a natural continuation of our mission to deliver accessible and affordable quality medicines to patients across Europe. This expansion will also enable Zentiva to achieve sustainable growth in one of the most dynamic sectors of the pharmaceutical industry.”
The newly launched biosimilar is a monoclonal antibody intended for the treatment of bone diseases. Following its approval through the EMA’s centralized procedure, the drug is expected to gradually appear in European markets starting this month.
Zentiva’s foray into biosimilars is part of a broader strategic development plan aimed at diversifying its portfolio beyond traditional generic medications. As biologics account for an increasing share of healthcare expenditures in Europe, biosimilars play a crucial role in ensuring the sustainability of healthcare systems and improving patient access to modern therapies.
The company focuses on the health and comfort of all generations, developing, manufacturing, and supplying quality medicinal products for over 100 million people in more than 30 countries across Europe and beyond. Zentiva ensures the safety of its products through four wholly-owned manufacturing facilities and a wide network of external production partners.
With a workforce of over 5,000 unique talents, Zentiva is dedicated to those who rely on its medicines every day. As a private company, it is committed to sustainable growth and looks to the future with ambitious plans.
For more information about Zentiva, visit their official website at www.zentiva.com.
