CinnaGen today announced that the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of Zandoriah® (teriparatide), a biosimilar to Forsteo® (teriparatide).
This recommendation represents CinnaGen’s first regulatory milestone within the European Union and marks a significant step in the company’s strategic expansion into highly regulated global markets.
The EMA’s positive opinion paves the way for a final decision by the European Commission in the coming weeks. Upon adoption, the centralized marketing authorization will be valid across all 27 EU Member States, as well as Iceland, Liechtenstein, and Norway.
Expanding Access to Complex Biologics in Europe
Osteoporosis affects millions of patients across Europe and remains a leading cause of fractures and disability among aging populations. The introduction of high-quality biosimilars plays a critical role in expanding treatment access while supporting the sustainability of healthcare systems.
Zandoriah® is indicated for the treatment of osteoporosis in adults at increased risk of fracture, including men and postmenopausal women, as well as in patients with osteoporosis associated with long-term systemic glucocorticoid therapy.
A Milestone in Global Regulatory Recognition
The positive opinion reflects the robustness of CinnaGen’s scientific development, manufacturing excellence, and regulatory standards, aligned with European requirements.
“This milestone represents more than product approval,” said Business Development Team. “It confirms that our research, development, and manufacturing capabilities meet the rigorous standards of the European Union. Entering the EU market reflects our long-term vision to contribute to global healthcare systems with accessible, high-quality biologic medicines.”
About Zandoriah®
Zandoriah® is a biosimilar medicine. This means it has been developed to be highly similar to a biological reference medicine already authorized in the European Union. The reference medicine for Zandoriah® is Forsteo® (teriparatide).
It has demonstrated comparability in accordance with EMA biosimilar guidelines. Biosimilarity has been established based on comprehensive comparability studies demonstrating similar quality, safety, and efficacy.
Teriparatide, the active substance in Zandoriah®, is identical to a portion of the human parathyroid hormone (PTH). It stimulates new bone formation by activating osteoblasts (bone-forming cells), increases calcium absorption from the diet, and reduces urinary calcium loss.
About CinnaGen
Founded in 1994, CinnaGen is a leading biopharmaceutical company dedicated to the development and manufacturing of high-quality biosimilars and 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.
For more than three decades, CinnaGen has built advanced R&D infrastructure and state-of-the-art, fully integrated manufacturing facilities that bridge scientific discovery with industrial-scale production. From upstream and downstream bioprocessing to formulation, aseptic filling, and comprehensive quality systems, the company has established one of the region’s most mature biotechnology platforms.
Manufacturing excellence at CinnaGen is anchored in strict adherence to EU-GMP standards and global regulatory requirements, ensuring safety and efficacy throughout the entire product lifecycle. With a network spanning more than 40 countries across Eurasia, the Middle East, Latin America, and Africa, CinnaGen expands global access to biologics and contributes to more sustainable healthcare systems worldwide.
