European Commission Approves CinnaGen’s Zandoriah® (teriparatide biosimilar) for Osteoporosis in Adults

Zandoriah® is CinnaGen’s first medicine to receive European Union marketing authorisation, expanding the availability of EU-authorised teriparatide biosimilars for adults with osteoporosis. This reflects the company’s long-term investment in biologics development, quality systems, and regulated-market readiness.

TEHRAN, Iran – 6/15/2026 – CinnaGen today announced that the European Commission has granted centralised marketing authorisation for Zandoriah® (teriparatide), a biosimilar to the reference medicine Forsteo®, for the treatment of osteoporosis in adults. 

The authorisation provides a centralised regulatory basis for marketing Zandoriah® across the 27 European Union Member States, as well as Iceland, Liechtenstein, and Norway, subject to applicable national market access, pricing, reimbursement, and launch requirements.

This milestone represents CinnaGen’s first marketing authorisation within the European Union and marks a significant step in the company’s strategic expansion into highly regulated markets. It also provides an EU-authorised basis from which CinnaGen and its partners can plan country-level access.

Addressing a High-Need Osteoporosis Landscape

Zandoriah® enters a European healthcare landscape where osteoporosis remains a major clinical and economic challenge. In 2019, osteoporosis was associated with an estimated 4.3 million fragility fractures across the EU27, the United Kingdom, and Switzerland, generating healthcare costs in excess of €56 billion annually. At the same time, a substantial treatment gap persists, with an estimated 71% of women eligible for osteoporosis therapy remaining untreatedⁱ.

Biosimilar medicines can play an important role in this context by supporting competition, healthcare-system sustainability, and the conditions for broader access to biological treatmentsⁱⁱ. By introducing an additional EU-authorised teriparatide biosimilar option, Zandoriah® supports CinnaGen’s long-term strategy to contribute to access through evidence-based development, quality alignment, and responsible market introduction.

Partnering Around an EU-Authorised Biosimilar

CinnaGen develops and supplies biosimilars through commercial, licensing, and distribution partnerships. With Zandoriah® now EU-authorised, the company is positioned to support partners on country-level launch planning, supply, quality and pharmacovigilance alignment, and tender participation across European markets.

CinnaGen’s approach to Zandoriah® is built on long-term investment in biologics development, integrated manufacturing capabilities, regulatory readiness, pharmacovigilance infrastructure, and quality systems aligned with global regulatory expectations.

“A European marketing authorisation is never created in one moment. It reflects years of investment in scientific capability, people, quality systems, manufacturing discipline, and regulatory standards,” said Dr. Haleh Hamedifar, Chairperson of CinnaGen Group. “Zandoriah® is a meaningful milestone in CinnaGen’s global journey and a reflection of our belief that access must be built on standards.”

“For CinnaGen and our partners, authorisation is the beginning of disciplined execution,” said Mehran Montajabi Niyat, CEO of CinnaGen. “Zandoriah® gives partners an EU-authorised biosimilar around which to plan launch, market access, and long-term supply.”

Country-level availability, pricing, reimbursement, and launch timelines may vary according to local regulatory, market access, and partner arrangements.

About Zandoriah®

Zandoriah® is an EU-authorised biosimilar medicine containing teriparatide, the active fragment (1–34) of endogenous human parathyroid hormone (PTH). It is authorised as a 20 micrograms/80 microlitres solution for injection in a pre-filled pen and should be used in accordance with the approved Summary of Product Characteristics and applicable local regulations.

Zandoriah® 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 is a parathyroid hormone (PTH) analogue used in adults for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk of fracture.

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.

_{Forsteo® is a registered trademark of Eli Lilly and Company. All other trademarks are the property of their respective owners.}