European Commission’s Approval of CinnaGen’s Teriparatide Signals New Phase of Global Growth
The European Commission’s authorization of Zandoriah®, an osteoporosis medication, marks a significant step in CinnaGen’s journey of international expansion
DUBAI, DUBAI, UNITED ARAB EMIRATES, July 3, 2026 /EINPresswire.com/ -- July 02, 2026: The European Commission has granted centralized marketing authorization for Zandoriah® (teriparatide), CinnaGen’s biosimilar to the existing Forsteo® medicine, designed to treat adult osteoporosis.The authorization provides a centralized regulatory basis for marketing Zandoriah® across 27 European Union Member States (EU27), as well as Iceland, Liechtenstein, and Norway, subject to the specific requirements of each country.
The approval represents an important milestone in CinnaGen’s expansion into highly regulated markets, providing an EU-authorized platform from which the company and its partners can advance market access and launch preparations across Europe. The European marketing authorization further supports accelerated registration pathways in Gulf Cooperation Council (GCC) countries, enabling CinnaGen to bring Zandoriah® to patients across the region more efficiently. Availability, pricing, reimbursement, and launch timelines remain subject to local regulatory requirements.
Dr. Haleh Hamedifar, Chairperson of CinnaGen Group, stated: “Zandoriah® is a significant milestone in CinnaGen’s global journey and a reflection of our belief that access must be built on standards. A European marketing authorization is never created in one moment. It reflects years of investment in scientific capability, people, quality systems, manufacturing discipline, and regulatory standards.”
Zandoriah® enters a European healthcare landscape where osteoporosis, a bone disease characterized by weak and fragile bones, 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 exceeding EUR 56 billion (approx. USD 63 billion). At the same time, a substantial treatment gap persists, with an estimated 71 per cent of women eligible for osteoporosis therapy remaining untreated.
Biosimilar medicines can play an important role in this context by supporting competition, healthcare system sustainability, and conditions for broader access to biological treatments. By introducing an additional EU-authorized teriparatide biosimilar option, Zandoriah® supports CinnaGen’s long-term strategy to contribute to access through evidence-based development, quality alignment, and responsible market introduction.
With Zandoriah® now authorized in the European Union, CinnaGen is actively engaging with partners seeking a reliable, long-term biosimilar platform for European markets. Supported by integrated capabilities across development, manufacturing, quality control, and supply, the company offers the operational scale, strength, and regulatory foundation required to support launches, procurement opportunities, and sustainable market growth.
Mehran Montajabi Niyat, CEO of CinnaGen, added: “For CinnaGen and our partners, authorization is the beginning of disciplined execution. Zandoriah® gives partners an EU-authorized biosimilar, enabling them to plan for launch, market access, and long-term supply. This discipline is built on more than three decades of experience.” Founded in 1994, CinnaGen’s journey reflects the steady accumulation of precision in developing, manufacturing, and supplying biosimilars in close collaboration with partners across global markets.
As healthcare systems across Europe continue to seek sustainable ways to expand access to biologic therapies, the approval of Zandoriah® positions CinnaGen to play a growing role in the region’s biosimilar landscape. Supported by a network of over 40 countries and decades of experience in biologics development and manufacturing, the company views its first European authorization not as a destination, but as the beginning of a broader strategy to build long-term partnerships and expand access to high-quality medicines in regulated markets worldwide.
CommuniGate Middle East
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