Pharmaceutical Business review

Sandoz launches generic iron sucrose injection in US market

The launch of iron sucrose injection follows approval from the US Food and Drug Administration (FDA). Credit: Markus Spiske on Unsplash.

The launch follows approval from the US Food and Drug Administration (FDA).

Iron sucrose is a key treatment for iron deficiency anaemia, affecting around five million people in the US, including those with chronic kidney disease (CDK).

The injectable is administered in dialysis centres and is approved for the same indications as the reference medicine, Venofer.

Venofer is sold in the US by American Regent, a Daiichi Sankyo group company.

The launch of the injectable, currently available nationwide, is expected to expand its portfolio of iron therapies in the US market, according to Sandoz.

Sandoz North America president Keren Haruvi said: “Our launch of iron sucrose proves again that we remain committed to pioneering access to more affordable medicines for patients with chronic conditions.

“We are proud to offer a high-quality, reliable alternative that helps patient, clinician and supply needs in the US.”

Iron deficiency anaemia arises when the body lacks sufficient iron to produce healthy red blood cells, essential for oxygen transport.

It is particularly prevalent in individuals with CDK, menstruating women, pregnant or breastfeeding women, and those with certain gastrointestinal disorders. Symptoms include fatigue, shortness of breath, and weakness.

Intravenous iron sucrose is often used when oral iron supplements are ineffective or poorly absorbed.

Sandoz developed the generic drug in collaboration with Greece-based Rafarm.

Recently, Sandoz settled patent litigation with Regeneron Pharmaceuticals regarding its aflibercept biosimilar.

The agreement allows Sandoz to introduce its biosimilar in the US market by the fourth quarter of 2026, or earlier under specific conditions.

Sandoz’s aflibercept biosimilar, Enzeevu, received FDA approval in August last year, and is deemed interchangeable with the reference medicine.