EMA clears CinnaGen biosimilar to Lilly’s Forsteo

Iranian biopharma CinnaGen has secured European marketing authorization for Zandoriah (teriparatide), a biosimilar to Forsteo, the osteoporosis drug from US pharma major Eli Lilly (NYSE: LLY).

Zandoriah is indicated for postmenopausal women and men at increased fracture risk, as well as glucocorticoid-induced osteoporosis. Regulators concluded the product matched Forsteo in quality, safety and efficacy after a full comparability review.

In a statement, the firm said it was: “proud to expand our biosimilar portfolio in Europe and contribute to improving patient access to high-quality biologic therapies”

Founded in 1994, CinnaGen has built a sizable biosimilars business spanning autoimmune, metabolic and other chronic diseases, with exports to more than 40 countries. The EMA approval strengthens its European footprint and signals growing regulatory credibility.

A shifting osteoporosis landscape

Teriparatide is one of the few anabolic treatments that actively builds bone rather than simply slowing bone loss. It has long occupied a niche role for patients at high fracture risk.

Global sales of teriparatide products have been estimated in the low single-digit billions of dollars annually in recent years, within an overall osteoporosis market worth more than $10 billion a year. Demand is expected to rise as populations age across Europe and beyond.

Competition has intensified since key patents on Forsteo expired. Other bone-building therapies include Tymlos (abaloparatide) and Evenity (romosozumab), offering physicians alternative mechanisms and pricing dynamics.

The entry of biosimilars has gradually compressed prices in several markets, although uptake can depend on national reimbursement systems and prescribing habits. In some countries, switching from originators remains cautious and uneven.

For Lilly, Forsteo has been a mature product for years, but it retains brand recognition in specialist care. Biosimilar entrants such as Zandoriah may test loyalty, particularly in cost-conscious healthcare systems.