Insulin safety in Russia: barriers and perspectives
The issues of national security were discussed at the conference in the press center "Interfax".
In 2013 GEROPHARM-Bio plant, the only industrial platform in Russia operating on the principle of full cycle, was opened in Obolensk (the Moscow region).
"From the very beginning, we realized that there should be a local technology of insulin production. Although, it was obvious that it should be the one, based on the full-cycle principle (from a scratch substance to a finished filled drug form)," comments Petr Rodionov, the head of GEROPHARM Group. "Only this approach can provide drug safety in the country. The key aspect is a strategic independence of our production from foreign suppliers of raw materials."
Today the plant capacity of GEROPHARM-Bio, certified according to the international quality standards of GMP, is enough to cover 25% of insulin demand in Russia. In the near future, the plant capacity might be two and more times increased in order to carry out the plans for the export of Russian insulins. "When we were developing this area, we set a goal to create a more cost-efficient technology than our competitors had, and we’ve managed to achieve it," says Petr Rodionov. Cost-efficient manufacturing process, stable reproducible technology and its high performance play an important role as all these factors have a direct impact on drug availability. Nowadays insulin safety is under control. We have every opportunity to produce all necessary drug products in sufficient quantity. We are able to do it quickly, efficiently and at affordable prices".
Today Rinsulin® R (short-acting) and Rinsulin® NPH (average duration), genetically engineered human insulins, are being manufactured in different delivery forms (vials, cartridges, pre-filled insulin pens) at the plant. The quality of the substance is confirmed by three independent certified European laboratories - ProteomeFactoryAGBerlin, ProlyticGmbHFrankfurtamMain, LaborL+SAG, which proved that our substance satisfies the requirements of British and American Pharmacopoeias.
During the next 3-4 years GEROPHARM is planning to introduce a full pipeline of analogues: lispro, aspart, glargin, degludec. Due to the created over the last five years teсhnological platform, which consists of a modern plant and a world class research centre, GEROPHARM can deal with a number of issues connected with the development and following full-cycle drug production. With such approach it will be possible to introduce new products of high quality to the market. So, it will lead to the success of import substitution programme.
Today the progress of import substitution in the sphere of insulin provision can be measured in figures. It is expected that the company’s share growth in the segment of genetically engineered human insulins will be increased from 1,3% to 10% in 2015. However, the issues concerning import substitution bring up the questions of company’s internal competences, and the problems of providing market access for the locally manufactured drug products as well as the problems of trust strengthening of both medical and patient communities.
With the adoption of the Federal law №44 “On the contract system in the sphere of purchases of products, work or services for state and municipal needs”, the local companies got an equal access to the market of government procurement, which did not exist up to this day. Nowadays, a transparent law-enforcement practice is being formed in the regions. The violations connected with the purchases according to the trade names or lot protection are fading away. At the same time, new support measures are being developed at the federal level. Some special investment contracts can serve as one these measures.
Apart from existing legal mechanisms, the medical and patient communities should also follow this idea in order to achieve success in the sphere of import substitution. The process of drug manufacturing and market access are not just meant by true import substitution. It is the general positive result: when doctors prescribe, and patients buy drugs produced in Russia. The manufacturers’ transparent policy makes it possible to overcome any kind of prejudice that occur in our society.
"Patients’ trust is our main reference point, and quality – the main priority not just in short-term breakthrough, but in a long-term outlook," says Petr Rodionov, the head of GEROPHARM. "In many respect, due to this policy the company’s share in supplies has increased significantly during this year. I am sure that import substitution has already taken place in our country, and we are doing our best to bring new drug products necessary for patients to the market".