On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinion, recommending the granting of a marketing authorization for CinnaGen’s teriparatide biosimilar, Zandoriah, for the treatment of osteoporosis.
Teriparatide is a recombinant form of parathyroid hormone (PTH). It is identical to a portion of human PTH,and intermittent use activates osteoblasts more than osteoclasts, leading to an overall increase in bone formation. This makes it an effective anabolic, i.e., bone growing, agent. It is indicated for the treatment of osteoporosis in postmenopausal women and men at high risk of fracture, as well as for glucocorticoid-induced osteoporosis in these populations. The originator product is Eli Lilly’s Forteo/Forsteo (teriparatide) [1]
CinnaGen’s teriparatide biosimilar, Zandoriah, will be available as a 20 µg/80 µl solution for injection in pre-filled pens. Data submitted to the CHMP demonstrate that Zandoriah has comparable quality, safety, and efficacy to the reference product, Forsteo.
Zandoriah is recommended for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
If approved by the European Commission, Zandoriah would become the fifth teriparatide biosimilar authorized in the European Union (EU). Others include Accord’s Sondelbay, Theramex’s Livogiva, Stada’s Movymia, and Gedeon Richter’s Terrosa.
Zandoriah represesnts CinnaGen’s first biosimilar to receive a positive CHMP opinion for the EU market.
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 [2].
For over 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.
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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-teriparatide
2. GaBI Online - Generics and Biosimilars Initiative. Transforming healthcare: CinnaGen’s leadership in follow-on biologicals/ biosimilars development and market expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Mar 4]. Available from: www.gabionline.net/sponsored-articles/transforming-healthcare-cinnagen-s-leadership-in-follow-on-biologicals-biosimilars-development-and-market-expansion
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