European Commission Grants Marketing Authorisation for CinnaGen's Teriparatide Biosimilar Zandoriah, a First for Iranian Pharma
核心洞察
The European Commission granted centralised marketing authorisation for Zandoriah (搜索) (teriparatide), a biosimilar to Forsteo, for treating osteoporosis (搜索) in adults across all 27 EU member states plus Iceland, Liechtenstein, and Norway.
This marks the first-ever European marketing authorisation for an Iranian pharmaceutical company, representing a historic milestone for Iran's pharmaceutical industry.
Zandoriah (搜索) demonstrated comparable quality, safety, and efficacy to the reference product through comparability studies conducted in accordance with EMA biosimilar requirements.
The European Commission has granted centralised marketing authorisation for Zandoriah (搜索) (teriparatide), a biosimilar to the reference medicine Forsteo, for the treatment of osteoporosis (搜索) in adults. The decision, which follows a positive opinion from the European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (CHMP) during its February 2026 meeting, marks the first time an Iranian pharmaceutical company has received European Commission approval for one of its medicines.
The authorisation covers all 27 European Union member states — including Germany, France, Italy, Spain, the Netherlands, and Belgium — as well as the three European Economic Area (EEA) countries of Iceland, Liechtenstein, and Norway. For CinnaGen, this represents the company's first step into a highly-regulated global market setting.
"This marks a historic development that can be regarded as a major turning point in the history of Iran's pharmaceutical industry," according to the report from PHANA, the Iranian health and medicine news website.
Regulatory Pathway and Biosimilarity
The CHMP positive opinion followed a comprehensive scientific and regulatory evaluation process conducted under the European Union's biosimilar guidelines. The assessment included rigorous evaluation of quality documentation, advanced analytical data, comparative studies, preclinical and clinical data, quality assurance systems, and full compliance with the EU's strict Good Manufacturing Practice (GMP) requirements.
Zandoriah (搜索)'s biosimilarity was established through comparability studies conducted in accordance with European Medicines Agency (搜索) (EMA) biosimilar requirements, demonstrating comparable quality, safety, and efficacy to the reference product, Forsteo, originally developed by Eli Lilly.
The EMA's positive opinion also confirmed that CinnaGen's development, manufacturing, and quality control infrastructure fully complies with European Union regulatory standards — representing the highest level of international requirements in areas such as data transparency, product traceability, manufacturing controls, and post-marketing surveillance.
Notably, CinnaGen had already become the first Iranian pharmaceutical company to obtain European Union GMP certification in 2018, an achievement that laid the foundation for the current marketing authorisation.
Clinical Indication and Product Profile
Zandoriah (搜索) contains 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 is indicated for the treatment of osteoporosis (搜索) in postmenopausal women and men at increased risk of fracture, as well as osteoporosis associated with sustained systemic glucocorticoid therapy.
CinnaGen has been marketing teriparatide in Iran for more than a decade under the brand name Cinopar.
Addressing the Osteoporosis (搜索) Treatment Gap
The approval arrives against a backdrop of significant unmet need in osteoporosis (搜索) care across Europe. In 2019, osteoporosis was associated with an estimated 4.3 million fragility fractures across Europe, generating more than €56 billion in annual healthcare costs. Despite this burden, a substantial treatment gap persists, with data indicating that an estimated 71% of women eligible for osteoporosis therapy remain untreated.
Biosimilar medicines can contribute to treatment availability by increasing the number of approved therapeutic options within healthcare systems, supporting competition and system sustainability. By expanding the availability of high-quality treatment options, biosimilars can help support broader patient access while contributing to the long-term sustainability of healthcare systems.
Commercialisation and Next Steps
CinnaGen develops and supplies biosimilars through commercial, licensing, and distribution agreements. Following the authorisation, the company and its partners will pursue state-level activities related to market access, product supply, pharmacovigilance, and participation in procurement and tender processes, subject to local requirements.
Dr Haleh Hamedifar, Chairperson of CinnaGen Group, stated: "The granting of a European marketing authorisation follows a multi-year process involving product development, manufacturing, quality systems, and regulatory review."
Mehran Montajabi Niyat, CEO of CinnaGen, also commented: "The authorisation provides a regulatory basis for future launch planning and commercial activities with partners in European markets."
Country-level availability, pricing, reimbursement, and launch timelines may vary according to local regulatory, market access, and partner arrangements. CinnaGen has experience in commercial operations across more than 40 countries and intends to apply these established capabilities in support of future commercialisation efforts across Europe.