Zentiva has made a significant entry into the biosimilars market by launching its first biosimilar monoclonal antibody throughout Europe. This strategic move aims to provide more accessible and high-quality biological medicines to patients across the continent. The announcement was made on December 1, 2025, following the approval from the European Medicines Agency (EMA).
With this launch, Zentiva reinforces its commitment to enhancing patient access to essential treatments. “Today’s official presentation is a key moment for Zentiva,” said Steffen Saltofte, the company’s Chief Executive Officer. “We have taken a significant step into the field of biological medicines. Biosimilar products are a natural progression of our mission to deliver affordable, high-quality medicines to patients across Europe.”
The newly introduced biosimilar is a monoclonal antibody designed for the treatment of bone diseases. This product has received a centralized approval from the EMA and will gradually become available in European markets starting this month. Zentiva’s entrance into the biosimilars sector is part of a broader strategic plan to expand its portfolio beyond traditional generic medicines.
As the share of biological medicines continues to grow within healthcare expenditures in Europe, biosimilar drugs play a crucial role in ensuring the sustainability of healthcare systems and patient access to modern therapies.
Zentiva is dedicated to improving health and comfort for all generations, focusing on the development, manufacture, and supply of quality medicinal products for over 100 million people in more than 30 countries globally. The company ensures the safety of its supplies through four wholly-owned manufacturing facilities and a wide network of external production partners.
Employing more than 5,000 unique talents, Zentiva is committed to those who rely on its medicines every day. As a private company, it aims for sustainable growth and looks to the future with an ambitious plan to broaden its reach in the pharmaceutical industry.
For more information, visit www.zentiva.com.
