GEROPHARM received marketing authorization for long-action insulin analog – glargine under RinGlar® invented name. The drug in two dosage forms - 3 ml cartridges and pre-filled disposable insulin pens RinAstra® II - will take part in the state procurement procedure in the autumn of 2019.
This is the fifth insulin in the company portfolio, which will complete the GEROPHARM line of human recombinant insulins and analogues.
RinGlar® will become the first insulin glargine, which will be produced in Russia on a full cycle basis – from substance to the finished dosage form. Today the only insulin glargine available on the Russian market is the Sanofi’s drug (of the foreign production).
The total insulin glargine market volume in Russia is about 8.2 bln* rubles.
The share of glargine consumption among basal analog insulin in Russia has reached 65.5% ** in 2018.
In addition, this drug is a global blockbuster and has significant export potential. According the company internal data, its total world sales exceed $ 12 bln.
Apart from providing Russian population with
reliable and affordable drug of the high quality, GEROPHARM
also focuses on the development of RinGlar® exports to Latin America, Southeast Asia, the Middle East and North Africa, the countries of the Persian Gulf and the European Union.
Insulin glargine bioanalogue technology development and production set up was carried out in accordance with the state program of the Russian Federation "Development of the pharmaceutical and medical industry."
Total cost of pharmaceutical development, clinical research and registration of RinGlar® amounted to 238.7 mln rubles. More than 53 mln rubles of which had been received from the Ministry of Industry and Trade as subsidies for conducting clinical trials.
Petr Rodionov, GEROPHARM Chief Executive Officer: «For last few years in a row we have made a breakthrough in the field of insulin production in Russia - we managed to create a production of high-quality, reliable and affordable full-cycle drugs and become the leader in the human recombinant insulins segment. Over the last month we received 3 marketing authorizations for ultrashort, medium duration and long acting insulin analogues.
This is evidence of the GEROPHARM complex approach to solving the problem of diabetes, a serious step towards ensuring the country's independence from the foreign insulin substances supplies and our contribution to ensuring drug safety in Russia. All this allows us to count on achieving leadership positions in the domestic insulin market by the end of 2021».
High comparability with the original drug, quality, reliability, efficacy and safety of the GEROPHARM insulin was proven within physicochemical, preclinical and clinical trials.
The first phase of clinical trials was conducted on the Federal State Budgetary Institution National Medecal Research Centre of Endocrinology NMRCE) of the Ministry of Health of Russia and the Federal State Budgetary Institution Almazov National Medical Research Center of the Ministry of Health of Russia. And the third phase – in 14 clinics of Saint Petersburg, Kazan, Rostov-on-Don, Arkhangelsk, Krasnoyarsk, Moscow, Saratov and Petrozavodsk. The total number of participants in the two stages of clinical trials was 222 people.
GEROPHARM clinical trials successfully passed independent audits. Their results were presented to the Ministry of Health of the Russian Federation.
*International research company IQVIA data for 2018
** DDD – defined daily dose
Insulin glargine is a basal long-acting analogue of human insulin that supports normal physiological concentration of basal (background) insulin. It is the most widely used analogue of basal insulin and a reference comparator for all basal insulins.
Clamp trials is a regulatory requirement for insulin products registration in Europe, Russia, USA and other countries with high regulatory level. PK/PD equivalence of tested and reference products is examined in this study in clinical setting.
GEROPHARM is the first company,that conducted clamp trials in Russia. The company has significant investments in training of the specialists of research centers to conduct clamp trials at the level of international standards.
GEROPHARM is a Russian biotechnological company, a leader in the development and production of insulin. The company is the leader in human recombinant insulins in Russia since the end 2016. Today, GEROPHARM covers about 30% of the Russian Federation’s requirements for human recombinant insulin.
All stages of insulin production, including the biosynthesis of the molecule, are carried out at the company's own production facilities in the Russian Federation. In 2018, a new production site in Saint Petersburg was opened with the participation of the President of the Russian Federation.
Production facilities of the manufacturing site in Pushkin is 1000 kilos of substance per year, which will allow to cover full Russia’s demand in insulin (800 kilos) and to carry out the plans for the export.
The project has been implemented with the participation of state development institutions - RDIF, FRP.
Company endocrinological portfolio includes two human recombinant insulins –Rinsulin® R and Rinsulin® NPH as well as insulin analogues RinLiz® and RinLiz® Mix 25. 7 more products are being developed (insulin analogues and human recombinant insulins), 1 of them are expected to get registration in 2019.
Statistical data on the diabetes in Russia
4.6 million people with diabetes live in the Russian Federation; over the past 5 years, the incidence in the country has increased by more than 20%.