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New ultra-rapid-acting insulin from GEROPHARM has been registered

1 November 2023

GEROPHARM has obtained a marketing authorisation for RinFast® Nic ultra-rapid-acting insulin with insulin aspart as an active ingredient. This medicinal product is a biosimilar of Fiasp® which has problems with availability and accessibility in Russia today.

For many years, the national biotechnological company GEROPHARM has been bringing to the Russian market analogues of the most popular insulins to ensure medicinal security for patients with diabetes mellitus. Today, the company produces ultra-rapid-acting, rapid-acting, intermediate-acting and long-acting insulins: a total of 8 medicinal product items. GEROPHARM obtained a marketing authorisation for a new medicinal product RinFast® Nic, a biosimilar of Fiasp®.

Fiasp® manufactured by the Danish company Novo Nordisk is a sought-after ultra-rapid-acting insulin that effectively and safely keeps postprandial hyperglycaemia under control by physiologically simulating the human insulin response. However, today there is a shortage of this medicinal product on the Russian market, therefore it is rarely prescribed to adult patients with diabetes mellitus, as well as provided to children in limited quantities.

The manufacture of the Russian biosimilar will ensure the availability of ultra-rapid-acting prandial insulin within the country. Like other GEROPHARM insulins, RinFast® Nic will be manufactured in Russia on a full-cycle basis: from substance to the dosage form. Manufacturing will be performed at the company's own plants in St. Petersburg and the Moscow region, which meet high national and international GMP standards. The manufacturing volume will depend on the demand level.

The pen injector supplier will be the Swiss company Ypsomed, with which GEROPHARM has been co-operating for many years. Ypsomed is a leading developer and manufacturer of injection and infusion systems for medicinal product self-administration.

“Sanctions, restrictions, out-of-stock items are the reality in which we exist. This is why full-cycle domestic manufacture of the most in-demand modern insulins is so necessary. This is a guarantee of uninterrupted medicinal supply to patients with diabetes mellitus”, Petr Rodionov, General Director of GEROPHARM.

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