GEROPHARM intends to enter the Cuban market in the near future. The company submitted a case file to register all forms of presentation of human genetically engineered insulins Rinsulin® R and Rinsulin® NPH – bottles, cartridges and disposable pen injectors – to the national state regulatory authority CECMED*.
Submission of a case file became part of the company’s planned activities to celebrate the 30th anniversary of CECMED and the associated business mission led by the Federal State Institution “State Institute of Drugs and Good Practices”.
Vladislav Shestakov, Deputy Head of the Russian State GMP Inspectorate, Director of the Federal State Institution “State Institute of Drugs and Good Practices”: “As part of a business mission in Cuba, we have signed a cooperation agreement with the Cuban regulator CECMED in the field of inspection of pharmaceutical enterprises for compliance with the requirements of good manufacturing practice. We hope that cooperation will help increase the turnover of pharmaceutical products between our countries, since today Cuba is a full-fledged hub for entry of pharmaceutical companies into Latin American markets. It is great that such leading Russian companies as GEROPHARM are interested in developing exports in the region and can offer the market high-quality competitive products.”
The decision to register in Cuba was made by GEROPHARM in November 2018, when the director of CECMED, Dr. Rafael B. Pérez Cristiá, visited the new GEROPHARM plant for the production of insulin substance in the town of Pushkin (St. Petersburg). The preparatory phase took about 4.5 months.
National state regulatory authority CECMED has extensive expertise in drug registration and auditing. For instance, Cuban GMP is recognized in the Latin American region as a confirmation of product quality and evidence of manufacturer reliability for some other countries in the region.
The Cuban market has good development prospects in terms of biotechnology and production localization. The country has already created an appropriate infrastructure, as well as proprietary developments and willingness to cooperate with foreign manufacturers.
Currently, the Cuban market is represented mainly by human genetically engineered insulins. The need of the population for these socially significant medicines is provided by the state.
Pyotr Rodionov, GEROPHARM CEO: “This is the first step in active growth of export of our high-quality products in the Latin America region. In the short term, we intend not only to register genetically engineered insulins, but also expand our portfolio, as well as use the experience gained for the significant development of an export-oriented business model and increase our presence in the region by entering other markets. The priority countries for us are Argentina, Uruguay, Honduras, Guatemala, El Salvador, Mexico, Chile, Bolivia, Costa Rica, Peru, Ecuador, Brazil and Nicaragua.”
Diabetes mellitus is an important problem in Latin America. According to the IDF data for 2017, the number of patients with diabetes in the region was estimated at 26 million people, and this figure is constantly growing. The predicted value of patients by 2045 is 42 million people (+62 %). In terms of costs associated with this disease, Latin America is one of the leading regions among developing countries: 29.3 billion USD per year**.
Some states, such as Brazil, Argentina and Mexico, have developed pharmaceutical industries. At the same time, Brazil, Chile, Argentina and Cuba are characterized as the most authoritative regulators in the region, and obtaining registration in these countries confirms the compliance of drugs and case files with the highest requirements.
* CECMED – Center for State Control of Medicines, Equipment and Medical Devices of Cuba
** IDF DIABETES ATLAS, Eights edition 2017
GEROPHARM – is a national manufacturer of biotechnological products providing for medicinal safety of Russia. The company is engaged in full production cycle of drugs, invests into technological development and creation of a modern pharmaceutical infrastructure. Fields of GEROPHARM expertise: psychoneurology, ophthalmology, endocrinology and gynecology. The company is expanding its product portfolio – in its proprietary R&D center, drugs are being developed for treatment of socially significant diseases.
Today GEROPHARM is the only one Russian manufacturer of insulin, produced on a full-cycle basis. It covers 30 % of demand for genetically engineered insulins in the RF. The Company has been occupying the first position by sales volume among the manufacturers of human genetically engineered insulin monomolecules since the end of 2016. Both company plants – in Obolensk (Moscow Oblast) and Pushkin (St. Petersburg) have the capacity to produce this socially significant drug.
At the same time, the line manufacturing capacity at the site in Pushkin is 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.
Since 2011, the company portfolio includes two human genetically engineered insulins – Rinsulin® R and Rinsulin® NPH, 7 more products are being developed (insulin analogues and HGEI), 4 of which are already at the registration stage in Russia.