GEROPHARM received registration certificates for lispro and lispro biphasic insulins under the trade names RinLis® and RinLis® Mix 25 in two forms of presentation – cartridges and RinAstra®II disposable 3 ml pen injectors.
These are the first Russian analogues of insulin of ultrashort and medium duration of action in the GEROPHARM portfolio. The company will produce them on a full-cycle basis – from substance to the finished dosage form. This is another step towards ensuring the country's independence from the supply of imported insulin substances.
Currently, insulin lispro is represented on the Russian market only by Eli Lilly’s foreign drugs. The entry of Russian biosimilars into the market is sure to make therapy more accessible for patients.
RinLis® and RinLis® Mix 25 will take part in the public procurement procedure as soon as this fall.
The total volume of the Russian insulin lispro and lispro mix market is more than 1.9 billion* rubles. In addition, these analogues, being world blockbusters, have a high export potential. According to the company’s internal estimates, the worldwide sales of lispro insulin amount to about $6 billion, and lispro biphasic insulin – to more than $2.5 billion. GEROPHARM is also focused on export development of RinLis® and RinLis® Mix 25 to the following regions: Latin America, Southeast Asia, the Middle East and North Africa, the Gulf countries and the European Union.
The development of technology and the arrangement of production of insulin lispro biosimilars were carried out within the framework of the Russian Federation state program named “Development of pharmaceutical and medical industries”.
In 2013, a state contract was signed between the Ministry of Industry and Trade of the Russian Federation and GEROPHARM on the development of a technology for the production of substances and finished dosage forms, which involved co-financing of the research and development work. In addition, the company received subsidies for clinical trials.
The total cost of pharmaceutical development, clinical research and registration of RinLis® and RinLis® Mix 25 drugs amounted to 407.8 million rubles, of which more than 114 million rubles were allocated by the Ministry of Industry and Trade of the Russian Federation as measures of state support.
Pyotr Rodionov, GEROPHARM CEO: “GEROPHARM insulins appeared on the Russian market in 2011, and in 5 years we have taken the lead. For GEROPHARM, expansion of the drug portfolio in the field of endocrinology comprises a comprehensive approach to solve the problem of diabetes and contribute to the country’s drug safety. We never rest on our laurels: 8 products are being developed, 2 of them are at the registration stage. Thanks to the sate support, it is now possible to implement the project of bringing Russian insulin biosimilars to the market.”
The insulin development was carried out by internal experts of the company in its own research center in accordance with GLP, GCP and GMP standards.
High compatibility with the originator drug, quality, reliability, effectiveness and safety of the drugs have been proven in the course of physico-chemical, preclinical and clinical trials.
A total of 286 people took part In clinical trials, the first phase of which was carried out on the basis of the Federal State Budgetary Institution “National Medical Research Center of Endocrinology” of the Ministry of Health of the Russian Federation and “BioEq”, and the third one – in 17 clinics.
It is worth noting that GEROPHARM was the first pharmaceutical company to conduct clamp studies in Russia. To make sure that the quality of their performance meets international standards, the company invested in training of external experts.
GEROPHARM clinical trials have successfully passed independent audits, the results of which were presented to the Ministry of Health of the Russian Federation.
* Data from the international research company IQVIA for 2018 on the following international nonproprietary names in total: lispro insulin, lispro biphasic 25 insulin and lispro biphasic 50 insulin.
GEROPHARM is a Russian biotechnological company, a leader in insulin development and production. The Company has been occupying the first position by sales volume among the manufacturers of human genetically engineered insulins (HGEI) since the end of 2016. Today, the company provides about 30 % of the Russian Federation demand for HGEI.
All stages of insulin production, including the molecule biosynthesis, are carried out at the company’s own production facilities in the Russian Federation. In 2018, the company held an opening ceremony for a new factory in Pushkin (St. Petersburg) with participation of the Russian President, Vladimir Putin.
The line manufacturing capacity at the site in Pushkin is over 1,000 kg of substance per year, which, after reaching the design capacity, will allow to fully satisfy the needs of Russian residents in insulin (about 800 kg per year) and will expand the company’s export capabilities.
The project was implemented with participation of the state development institutions – the Russian Direct Investment Fund, the Fund of Industrial Development.
The company’s portfolio in the field of endocrinology includes two human genetically engineered insulins (HGEI) – Rinsulin® R and Rinsulin® NPH, as well as an analog of insulin with a medium duration of action RinLis® Mix 25. Another 9 products are being developed (insulin analogues and HGEI), 3 of them are expected to be registered in 2019.
Statistics on the number of people diagnosed with diabetes mellitus in Russia and the incidence rate
4.6 million people with diabetes mellitus live in the Russian Federation, over the past 5 years, the incidence rate in the country has grown by more than 20 %.