The solemn opening of the workshop for the production of biotechnological substances for the reproductive health of women took place at the Medsintez Plant

On November 19, 2022, the Medsintez Plant, which has the highest FSH production capacity in the world, held a grand opening of the workshop for the production of biotechnological substances for women's reproductive health. Since 2018, the Medsintez Plant, in cooperation with iVFarma, has been producing the first Russian preparation of recombinant follicle-stimulating hormone (FSH) for the treatment of human infertility – Primapur®. The Medsintez Plant produces the substance of this drug and the finished dosage form in pre-filled disposable syringe pens.

With the opening of the new workshop for the production of biotechnological substances, the plant has obtained new production facilities to provide domestic medicine with modern highly-demanded drugs. Thus, the production capacity of the FSH preparation at the plant is up to 30 grams of the substance, up to 1 million disposable syringe pens per year. The Medsintez Plant is ready to meet 200% of the annual demand for FSH preparations in Russia.

Representatives of the Government of the Russian Federation, the Ministry of Health of the Sverdlovsk Region, the Ministry of Industry and Science of the Sverdlovsk Region, as well as leading Russian experts in the field of healthcare and reproductive health, came to assess the level of ultra-modern production at the Medsintez Plant.

Vladimir Yakushev, Plenipotentiary Representative of the President of the Russian Federation in the Urals Federal District, got acquainted with the production of the plant, noting the level of import substitution and the contribution to the reproductive health of citizens of our country.

«Today, we can say with confidence that the medical cluster in the Middle Urals has been reinforced with another effective bundle. The biotechnologies of Medsintez and iVFarma form synergy with the highly professional specialists of the Mother and Child clinics. Thus, domestic medicines for women's reproductive health are already available and continue to be developed. Health care professionals, and patients even more so, can be sure that reproductive health products will always be available,» Vladimir Yakushev said.

The Russian-made FSH preparation is needed today in order to provide high-tech medical care in the Russian Federation on the way to overcoming the reproductive problems of the population. Within the framework of the Federal Law of November 21, 2011 No. 323-FZ On the Fundamentals of Protecting the Health of Citizens in the Russian Federation, citizens are widely provided with affordable infertility treatment through the in vitro fertilization (IVF) procedure. Primapur® has passed all stages of development and production in the Russian Federation, it is used in the treatment of infertility by IVF methods and included in the list of vital drugs.

At the opening of the workshop, Andrey Shastin, Deputy Minister of Health of the Sverdlovsk Region, appreciated the plant's contribution to solving the state task of demographic development of the country.

«Now, it is very important to provide help to those families that cannot have children. Preserving and increasing the population of Russia is an extremely important task. And the medicine, which is produced at this plant, is the key to ensuring the in vitro fertilization procedure. Until recently, only imported drugs were present on the market, which made us dependent. Having deployed production in the country, we are becoming absolutely independent and getting a more affordable price for a drug of world-class quality,» Andrey Shastin said.

To date, 25 commercial batches of Primapur® have already been produced. The medicine is used in more than 80% of medical centers specialized in the treatment of human infertility throughout Russia. More than 30,000 women have already received therapy with the Russian FSH preparation.

The Medsintez Plant was the first in Russia to start producing a dosage form of FSH convenient for patients in the form of disposable syringe pens, which is a consumer advantage and allows the drug to compete with the largest foreign manufacturers. The Primapur® syringe pen is registered with Roszdravnadzor as a medical device. This product form is the most demanded and convenient for patients.

Mark Kurtser, Academician of the Russian Academy of Sciences, Doctor of Medical Sciences, Professor, General Director, Member of the Board of Directors of the Mother and Child group of companies noted the high quality of the preparation and the annual increase in demand for Primapur®/

«We have conducted the third phase of clinical trials and seen that the drug is of very good quality, with no side effects. The use of this drug is doubling every year,» Mark Kurtzer said.

Dilorom Kamilova, Chief IVF Specialist at the Mother and Child Group of Companies, Candidate of Medical Sciences, Chief Physician of the Women's Center of the Mother and Child Clinic in Kuntsevo, noted that Primapur had proven its effectiveness and safety during its use in clinical practice. Maria Ganikhina, reproductologist, head of the IVF department of the clinical hospital Mother and Child in Tyumen, said that, over the past three years, their patients gave birth to about a thousand children with the help of this drug.

Solving the issues of import substitution, the company conducts research and development work to prepare for the production of other hormonal preparations necessary for the IVF procedure. New preparations of human chorionic gonadotropin and human gonadotropin-releasing hormone antagonist are currently at the stage of preliminary work before being submitted for registration with the Russian Ministry of Health. At the moment, the production of such preparations in the Russian Federation is especially important in order to ensure the availability of IVF treatment methods and the uninterrupted supply of drugs to the medical centers of our country.

Alexander Petrov, Chairman of the Board of Directors of the Medsintez Plant, shared his plans to develop the production of drugs for reproductive health.

«The first drug that we localized in this workshop was Primapur®, a human follicle-stimulating hormone that is used in IVF procedures. Currently, human chorionic gonadotropin and the Cetrorelix drug, which is also used in IVF procedures, are under development, which will allow creating a full cycle of these drugs. I think we will be able to bring them to the market in 2025 The drugs are now being registered in the Russian Federation,» Alexander Petrov said.

High-tech Russian production at the Medsintez Plant ensures a high level of quality and safety of manufactured medicines. At the same time, domestic production of medicines does not depend on rate fluctuations, which means that it offers favorable prices for finished products in comparison with imported analogues. This is especially important for consumers in today's difficult economic situation.

The production of drugs for reproductive health helps solve not only the country's tactical task – import substitution, but also the strategic one – ensuring the drug safety of Russia; in addition, these drugs can enter the world markets, says Alexander Petrov, deputy of the State Duma of the Russian Federation, member of the Health Committee.

«In Russia, there are approximately 570 plants producing medicines and about 10 sites that produce substances, that is, raw materials for production. This is a serious production in the Urals and a true element of the national drug safety system,» Alexander Petrov said.