Following the EU authorisation of its teriparatide biosimilar, the company is extending its European development plans.
CinnaGen is advancing four monoclonal antibody programmes through late-stage development for theEU market, extending its European strategy following the marketing authorisation of its teriparatide biosimilar, Zandoriah.
For pharmaceutical manufacturers and partners gathering at CPHI Milan 2026, the update raises a wider question: what does it take to build the scientific expertise, manufacturing systems and organisational discipline needed for sustained participation in European pharmaceutical markets?
The European Commission granted Zandoriah an EU marketing authorisation on 27 April 2026, following a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use. The marketing authorisation holder is CinnaGen Co. Unipessoal Lda., Portugal.
The capabilities behind the next chapter
CinnaGen's activities span biological research, process development, manufacturing and quality control, alongside international collaboration. Its European development plans bring these capabilities together with analytical evidence, regulatory preparation and pharmacovigilance.
Dr Haleh Hamedifar, Chairperson of CinnaGen Group, is available to discuss the decisions behind this work: developing specialist teams, establishing consistent processes and quality practices, and sustaining investment in programmes whose development extends over many years.
The Group's wider work includes rare and complex diseases, such as mucopolysaccharidosis type I and haemophilia. This experience adds another dimension to the discussion: how companies choose development priorities when patient populations are small and scientific requirements remain demanding.
International collaboration is also part of CinnaGen's approach, including licensing, research partnerships and technology transfer. These activities offer a practical perspective on how technical knowledge can be developed within an organisation and shared across partners and markets.
Development and regulatory context
The four antibody programmes remain in development and are not presented as EU-authorised medicines. Any future approvals are subject to the applicable scientific and regulatory processes. Zandoriah's authorisation applies to that medicine; authorisations and availability across the wider portfolio vary by product and country.
About CinnaGen
CinnaGen is a biopharmaceutical developer and manufacturer of high-quality, complex biologic medicines. Guided by the vision of creating a healthier world through affordable biologics, the company advances therapies across multiple therapeutic areas, including autoimmune diseases, oncology, metabolic disorders, infertility, and infectious diseases. Since 1994, CinnaGen has built advanced R&D infrastructure and state-of-the-art, fully integrated manufacturing facilities. From upstream and downstream bioprocessing to formulation, aseptic filling, and comprehensive quality systems, the company has established one of the region’s most mature biopharmaceutical platforms. Manufacturing excellence at CinnaGen is anchored in strict adherence to EU-GMP standards and global regulatory requirements. With a network spanning Eurasia, the Middle East, the Americas, and Africa, and marketing authorization secured in the European Union, CinnaGen continues to expand global access to biologics and contribute to more sustainable healthcare systems worldwide.
Media contact: Eyesun Jamali | Head of Group Brand & Executive Communicationsjamalia@cinnagen.com | CinnaGen website
Regulatory reference: European Medicines Agency - Zandoriah EPAR