GEROPHARM registered the first Russian insulin bioanalogue
GEROPHARM received a registration certificate for two-phase insulin lispro under the trade name RinLiz®.
These are the first Russian bioanalogues of ultrashort and medium duration insulin in the GEROPHARM portfolio.
The company plans to produce them on a full cycle basis – from substance to finished dosage form.
Now on the Russian market insulin lispro is represented only by foreign preparations from the company Eli Lilly.
The release of Russian biosimilars will make therapy more accessible for patients.
Preparations will take part in the public procurement procedure starting in fall 2019.
The total volume of the Russian insulin market lizpro and lispro mix is more than 1.9 billion rubles. Moreover, they have a fairly high export potential, as they are world blockbusters.
According to internal estimates of the company, sales of insulin lispro in the world are about$6billion, and two-phase lispro is over 2.5 billion and the European Union (not clear if these words are part of the sentence).
The development of technology and the organization of the production of biosimilars insulin lisprod was carried out within the framework of the state program of the Russian Federation “Development of the pharmaceutical and medical industry”.
The total cost of pharmaceutical development, clinical research and registration of RinLiz® and RinLiz® Mix 25 products amounted to about 408 million rubles, 114 of which were allocated by the Russian Ministry of Industry and Trade as a measure of state support.
In clinical trials, the first phase of which was conducted on the basis of the FSBI “NMITS Endocrinology of the Ministry of Health of Russia” and “Bioeq”, and about 290 people attended the 3rd of 17 clinics.
GEROPHARM became the first pharmaceutical company that conducted clamp studies in Russia. The company has even invested in the training of external experts in order to ensure that the quality of research is in line with world standards.
Clinical studies have successfully passed independent audits, the results of which were submitted to the Ministry of Health of the Russian Federation.