European Commission authorizes CinnaGen’s osteoporosis biosimilar Zandoriah in EU

The European Commission has granted centralized marketing authorization for CinnaGen’s Zandoriah, a teriparatide biosimilar for adult osteoporosis, opening the door to launches across the EU27 plus Iceland, Liechtenstein and Norway. The approval gives CinnaGen a regulatory platform to expand in Europe and supports its broader push into highly regulated global markets.

Why it matters: - The European Commission authorization gives CinnaGen an EU-wide regulatory base for Zandoriah®, a biosimilar version of teriparatide used to treat adult osteoporosis. - The decision can speed access planning across Europe, where osteoporosis remains a major health and cost burden. - CinnaGen also sees the authorization as a stepping stone for expansion into other highly regulated markets, including the Gulf Cooperation Council region.

What happened: - On July 2, 2026, the European Commission granted centralized marketing authorization for Zandoriah®. - The approval covers the 27 EU member states, plus Iceland, Liechtenstein and Norway, subject to each country’s local requirements. - Zandoriah® is CinnaGen’s biosimilar to Forsteo®. - The authorization allows CinnaGen and its partners to move ahead with market access and launch preparations across Europe.

The details: - Availability, pricing, reimbursement and launch timing still depend on local regulatory requirements in each market. - CinnaGen says the European authorization supports accelerated registration pathways in GCC countries. - Zandoriah® enters a market where osteoporosis caused an estimated 4.3 million fragility fractures across the EU27, the United Kingdom and Switzerland in 2019. - Those fractures generated healthcare costs of more than EUR 56 billion, or about USD 63 billion. - An estimated 71% of women eligible for osteoporosis therapy in that region remain untreated. - CinnaGen says biosimilar medicines can help increase competition, support healthcare system sustainability and widen access to biologic treatments. - The company says Zandoriah® adds another EU-authorized teriparatide biosimilar option. - CinnaGen says the product reflects an evidence-based development approach, quality alignment and responsible market introduction.

Between the lines: - The approval matters beyond one product because EU authorization can signal regulatory credibility to partners and health systems in other markets. - CinnaGen is using the approval to position itself as a long-term biosimilar supplier, not just a one-time entrant. - The company is leaning on more than three decades of experience, along with integrated development, manufacturing, quality control and supply capabilities, to compete in regulated markets. - Chairperson Dr. Haleh Hamedifar said the approval reflects years of investment in scientific capability, people, quality systems, manufacturing discipline and regulatory standards. - CEO Mehran Montajabi Niyat said authorization is the beginning of disciplined execution for launch, market access and long-term supply. - CinnaGen was founded in 1994 and says it works with partners across global markets.

What’s next: - CinnaGen is actively engaging with partners seeking a long-term biosimilar platform for European markets. - The company expects the EU authorization to support launch planning, procurement opportunities and sustainable market growth. - Future launches will still depend on country-by-country regulatory, pricing and reimbursement decisions. - CinnaGen says its first European authorization is the start of a broader strategy to expand access to high-quality medicines in regulated markets worldwide.

The bottom line: - Zandoriah’s EU approval gives CinnaGen a credible entry point into Europe’s biosimilar market and a regulatory asset it can use to push deeper into other international markets.