An Iranian Medicine, Authorised Across Europe

In April 2026, the European Commission granted marketing authorisation to Zandoriah, a medicine made by the Iranian company CinnaGen. It is the company's first EU authorisation. This page tells the full story: the company, the drug, the approval, and what the numbers do and do not show.

01. Who is CinnaGen?

CinnaGen was founded in 1994 and is one of the pioneers of biopharmaceuticals in Iran. The CinnaGen Group today is made up of eight companies.

• 1994 CinnaGen founded
• 2006 First biosimilar, developed with Germany's Fraunhofer Institute: Cinnovex, an interferon beta for multiple sclerosis, approved by Iran's FDA in 2007
• 2016 Launch of CinnoRA (adalimumab) for autoimmune diseases
• 2018 EU GMP certification for its plant
• 2021 Launch of Xacrel (ocrelizumab) for multiple sclerosis
• 2026 Positive opinion from the EMA's scientific committee in February, EU marketing authorisation for Zandoriah in April

By the company's own account, it has more than 19 biosimilars on the market, more than 25 in development, and over 50,000 litres of bioreactor capacity.

02. What Zandoriah is and does

Zandoriah's active ingredient is teriparatide, the active fragment of human parathyroid hormone. Most osteoporosis medicines slow the loss of bone. Teriparatide is different: it stimulates new bone formation, which is why it is used for patients at high risk of fracture.

Zandoriah is a biosimilar of Forsteo, made by Eli Lilly. A biosimilar is an equivalent version of a biological medicine, with comparable quality, safety and efficacy. Biologics are produced in living cells rather than by simple chemistry, which makes them among the hardest products in the pharmaceutical industry to make.

It comes as a pre-filled 20-microgram pen, injected under the skin once a day.

03. How much does it help patients?

In teriparatide's pivotal trial, published in the New England Journal of Medicine in 2001, 1,637 postmenopausal women with osteoporosis took part. At the 20-microgram dose, the same dose as Zandoriah:

• New spine fractures fell by 65% (5% versus 14% on placebo)
• Other fragility fractures fell by 53% (3% versus 6%)

For older people, a hip or spine fracture is not just pain. It often means disability and lost independence. Every fracture prevented is years in which someone can stand on their own feet.

04. What the EU approval means

This is a centralised authorisation: one approval valid in all 27 EU member states plus Iceland, Norway and Liechtenstein, 30 countries in total.

• 26 February 2026: positive opinion from the EMA's scientific committee (CHMP)
• 27 April 2026: marketing authorisation granted (per the EMA's website)
• Zandoriah is the fifth teriparatide biosimilar in the EU, competing with products from European and Indian companies
• The licence holder is CinnaGen's Portuguese subsidiary, registered in Funchal, Madeira

One important point: authorisation is not the same as sales. Each country still has its own pricing, reimbursement and launch process, so real sales in Europe are only now beginning.

05. How much does Europe need it?

• About 4.3 million osteoporotic fragility fractures in 2019 (EU, UK and Switzerland)
• More than €56 billion in annual healthcare costs
• About 71% of women who qualify for treatment do not receive it

Biosimilars usually bring prices down through competition and widen access. A treatment gap this large is exactly where a new option can make a difference.

06. Where CinnaGen operates

CinnaGen says it has commercial operations in more than 40 countries across Eurasia, the Middle East, Latin America and Africa. A list the company published in 2019 included Algeria, Morocco, Senegal, Jordan, Qatar, India, Sri Lanka, Vietnam, Serbia, Bosnia and Herzegovina, Moldova and Ecuador. It also has a plant in Turkey.

The company has also published patient figures for some products: about 80,000 patients have used CinnoRA since launch, and Xacrel has treated about 5,400 patients in Iran and 7,200 across the region. These are company estimates, not independently verified.

07. The woman at the helm

Dr Haleh Hamedifar has worked at CinnaGen since 2002 and has chaired the group since 2023. The company's first EU authorisation came under her chairmanship. Forbes Middle East ranked her ninth among its Top Healthcare Leaders of 2025. CinnaGen's CEO is Mehran Montajabi Niyat.

The takeaway: winning EU approval for a biological medicine means meeting a standard recognised anywhere in the world. Hundreds of scientists, engineers and workers built this, at a time when access to materials, equipment and the global financial system has not been simple.