CinnaGen secures historic European approval for osteoporosis biosimilar Zandoriah

UK—CinnaGen has secured a major regulatory milestone after the European Commission granted centralised marketing authorisation for Zandoriah® (teriparatide), a biosimilar to Eli Lilly’s Forsteo®, for the treatment of osteoporosis in adults.

The approval allows the company to market the medicine across all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway, subject to national pricing, reimbursement, and market-access requirements.

The decision marks CinnaGen’s first-ever marketing authorisation within the European Union and represents a significant step in the Iranian biopharmaceutical company’s expansion into highly regulated international markets.

The approval follows a positive opinion issued in February by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which concluded that Zandoriah demonstrated comparable quality, safety, and efficacy to the reference product.

Addressing a growing osteoporosis burden

Zandoriah enters a market where osteoporosis continues to place a substantial burden on patients and healthcare systems.

According to industry data, the disease was linked to approximately 4.3 million fragility fractures across the EU 27, the United Kingdom, and Switzerland in 2019.

These fractures generated healthcare costs exceeding €56 billion (US$64.4 billion) annually, while an estimated 71% of women eligible for osteoporosis treatment remained untreated.

The newly approved biosimilar contains teriparatide, a recombinant form of parathyroid hormone used to stimulate bone formation and reduce fracture risk in patients with osteoporosis.

 It is indicated for postmenopausal women, men at increased risk of fractures, and patients whose osteoporosis is associated with long-term glucocorticoid therapy.

Expanding access through biosimilars

CinnaGen believes the introduction of another EU-authorised teriparatide biosimilar could help improve patient access while supporting the sustainability of healthcare systems through increased competition.

With the approval in place, the company plans to work with its commercial and distribution partners on country-specific launch strategies, market-access activities, supply planning, pharmacovigilance alignment, and participation in public tenders across Europe.

The company said its biosimilar programme is supported by integrated manufacturing capabilities, regulatory expertise, and quality systems designed to meet international standards.

A landmark achievement for CinnaGen

Dr. Haleh Hamedifar, Chairperson of CinnaGen Group, described the authorisation as the result of years of investment in scientific expertise, manufacturing excellence, quality systems, and regulatory compliance.

Chief Executive Officer Mehran Montajabi Niyat said the approval provides partners with an EU-authorized biosimilar around which they can build long-term launch and supply strategies.

The approval has also attracted attention within the pharmaceutical industry, as it marks the first medicine from CinnaGen to receive European Union marketing authorisation.

Industry observers have described the achievement as a landmark moment for the company, which previously obtained EU Good Manufacturing Practice certification and has marketed teriparatide in Iran for more than a decade under the brand name Cinopar.

According to Fierce Pharma, country-level launch dates, reimbursement decisions, and product availability will vary across European markets depending on local regulatory and commercial arrangements.