What European Commission marketing authorisation of a teriparatide biosimilar means for osteoporosis
This month, the European Commission granted centralised marketing authorisation for Zandoriah (teriparatide), a biosimilar to the reference medicine Forsteo, for the treatment of osteoporosis in adults.
This is CinnaGen’s first marketing authorisation within the European Union. The new partner-led access opportunity in adult osteoporosis – supported by long-term investment in biologics development, quality systems, and regulated-market readiness – provides hope for patients across the EU’s 27 Member States, as well as Iceland, Liechtenstein, and Norway. Indeed, it marks the company’s first step into a highly-regulated global market setting.
Osteoporosis and biosimilar availability
Osteoporosis remains a major clinical and economic challenge. In 2019, osteoporosis was associated with an estimated 4.3 million fragility fractures across Europe, generating more than €56 billion in annual healthcare costs. At the same time, a substantial treatment gap persists, with data indicating that an estimated 71% of women eligible for osteoporosis therapy remain untreated.[i]
In this environment, biosimilar medicines can contribute to treatment availability by increasing the number of approved therapeutic options available within healthcare systems,[ii] supporting competition and system sustainability. By introducing an additional EU-authorised teriparatide biosimilar option, in line with CinnaGen’s long-term strategy, beneficial access potential for adult osteoporosis patients is created – this, made possible through evidence-based development, quality alignment, and responsible market introduction.
Indicated for the treatment of osteoporosis in postmenopausal woman and men at increased risk of fracture, as well as osteoporosis associated with sustained systemic glucocorticoid therapy, Zandoriah 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 its biosimilarity has been established through comparability studies conducted in accordance with European Medicines Agency (EMA) biosimilar requirements, demonstrating comparable quality, safety, and efficacy to the reference product.
For many patients, access to biologic therapies can be influenced by healthcare system capacity, affordability, and treatment availability. As a result, some individuals may face delays in receiving appropriate care or remain untreated despite clinical need. 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 partnerships
CinnaGen develops and supplies biosimilars through commercial, licensing, and distribution agreements. Following the authorisation, the company and its partners will now 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.”
Nevertheless, country-level availability, pricing, reimbursement, and launch timelines may vary according to local regulatory, market access, and partner arrangements. Bringing a biosimilar medicine to market requires years of development, advanced manufacturing capabilities, rigorous quality standards, and extensive regulatory review. Following approval, market access, supply, reimbursement, and distribution activities remain essential to ensuring patient availability across healthcare systems.
As stands, however, CinnaGen has experience in commercial operations across more than 40 countries and the company intends to apply these established capabilities and processes in support of future commercialisation efforts across Europe and, ultimately, the benefit of patients.
References
[i] SCOPE 2021: a new scorecard for osteoporosis in Europe | Archives of Osteoporosis | Springer Nature Link
[ii] European Medicines Agency and European Commission. Biosimilars in the EU: Information guide for healthcare professionals. 2019.
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. This seamless ecosystem provides the scale, reliability, and flexibility that our partners need.
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.
