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At least eight regions do not have a drug with the active ingredient glatiramer acetate for the treatment of patients with multiple sclerosis, the relevant patient organization told Izvestia. The drug is prescribed immediately after diagnosis and interruptions can lead to the progression of the disease. Roszdravnadzor indicated that there would be enough drug supplies for six months. Difficulties with the provision have arisen, in particular, due to the fact that the actual need for the drug is greater than stated. It also affected the fact that one of the major pharmaceutical companies has not been involved in public procurement since 2024, as it has abandoned the production of the drug. For more information, see the Izvestia article.

Which regions do not have the drug?

According to the All-Russian Public Organization of disabled people with multiple Sclerosis, the medicine is not given out in Moscow, St. Petersburg, Krasnoyarsk Territory, Khakassia, Ulyanovsk, Tyumen, Moscow and Rostov regions.

"The main reason why patients in these regions have difficulties with medicines is that pharmaceutical companies do not enter tenders under the state program "14 high—cost nosologies" or provide medicines in insufficient quantities," the patient organization says.

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Photo: IZVESTIA/Sergey Lantyukhov

There are more than 150,000 such patients in Russia, the All-Russian Union of Patients (VSP) said.

To solve the problem with the availability of the drug, some regions independently announce auctions. But pharmaceutical companies do not enter them either. According to the analytical company Headway Company, auctions for the purchase of the drug have not been held since the beginning of the year in Moscow, Chelyabinsk, Tyumen, Voronezh, Murmansk and Sverdlovsk regions, as well as the Krasnoyarsk and Kamchatka territories.

Izvestia sent inquiries to the regions asking them to confirm the existence of a problem with the drug and explain why it occurred.

The purchase of the drug with glatiramer acetate is carried out at the expense of the federal budget by the Ministry of Health, the Department of Health of the capital reminded Izvestia.

"In Moscow, patients who are shown therapy with this drug receive it in the required amount," they stressed.

Izvestia reference

According to the State Register of Medicines, preparations with acetate glatiramer in Russia were registered by domestic companies Biocad, R-Pharm, Pharmasynthesis and Pharmmental Group, as well as Israeli Teva.

The drug is used for the treatment of relapsing-remitting multiple sclerosis. The medicine is included in the list of vital and essential medicines, as well as the program "14 high-cost nosologies". Available by prescription.

It is also difficult to purchase drugs with glatiramer acetate in pharmacies, the patients stressed. Izvestia analyzed data from pharmacy aggregators and found out that currently medicines with this active substance are not available in pharmacies in at least 67 regions. Among them are the Murmansk, Ulyanovsk, Tyumen, Rostov regions, as well as Khakassia and the Krasnoyarsk Territory.

Аптека
Photo: IZVESTIA/Pavel Volkov

According to the analytical company DSM Group, 431 packages of the drug were sold through pharmacies in January-February 2024, 965 packages for the same period this year. 175.7 thousand packages of medicine were purchased for the state segment in 2024, and 44.2 thousand in January-February 2025. In both years, Biocad supplied the largest volume. Last year, it was also supplied to the state segment by Teva and Pharmasynthesis. This year, only Teva (196 packages in total).

The press service of Roszdravnadzor told Izvestia that currently there are more than 56.4 thousand packages of the drug on the Russian market, including in pharmaceutical distribution warehouses, most of which are of domestic production. The supervisory authority noted that this amount corresponds to almost half a year's need for this medicine.

Izvestia has sent inquiries to drug manufacturers asking them to clarify why companies are not going to tenders and whether they plan to.

Will they go to tenders

The Ministry of Health announced a tender for the purchase of medicines under the "14 VZN" program at the end of March 2025, its results will be announced on April 9.

The Biocad company, which remains the supplier of the drug with the active ingredient glatiramer acetate under the state program "14 VZN", reported that the company is producing the drug "in accordance with the approved production plan for 2025."

Производство
Photo: Global Look Press/Maksim Konstantinov

"We have not stopped or suspended its production," the company's press service stressed. They also noted that "given the shortage of the drug in the regions of Russia and understanding the high social responsibility towards patients, the company is taking all possible measures to increase the availability of therapy necessary for patients with multiple sclerosis." The manufacturer has reallocated available resources and prioritized providing patients with multiple sclerosis with the necessary therapy.

"A charity delivery of more than 5,000 packages of the drug has now been agreed to 16 regions, including Moscow, Tyumen, Sverdlovsk, Voronezh, Novosibirsk, Murmansk, Amur regions, as well as to the Krasnoyarsk Territory, Bashkiria, St. Petersburg and other regions," the company added.

They pointed out that the company is not the only manufacturer of a drug with this active ingredient on the Russian market.

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Photo: IZVESTIA/Pavel Volkov

The press services of R-Pharm, Pharmasynthesis, Pharmental Group and Teva did not respond to Izvestia's request. But a source in the pharmaceutical market said that R-Pharm has not been producing a drug with glatiramer acetate for a long time.

How critical is the lack of a drug

Difficulties with glatiramer acetate-based drugs arose due to the fact that the real need for the drug is greater than stated, Jan Vlasov, co-chairman of the VSP, told Izvestia.

Such drugs are supplied to some regions in a lower dosage than is necessary for normal therapy, which is why problems with the drug have arisen, he said.

Where it was necessary to put in a dosage of 40 mg / ml, they sent 20 mg/ml, — explained Yan Vlasov.

таблетки
Photo: TASS/Christin Klose

Also, according to him, pharmaceutical companies do not go to auctions until they get the average cost of the drug they need from the Ministry of Health.

— As a result, the patient can expect an auction for a year, but he does not have that time, — said Yan Vlasov.

Nikolay Bespalov, Director of Development at the RNC analytical company, noted that difficulties may arise due to the uneven distribution of medicines across regions.

"Since the drug is prescribed to patients on a federal basis, it should not be in pharmacies in large quantities," he added.

аптека
Photo: IZVESTIA/Zurab Javakhadze

In multiple sclerosis, the fibers of the central nervous system are affected. As a result, the impulses are transmitted with failures or stop being transmitted altogether, Ekaterina Demyanovskaya, a neurologist at the Hemotest laboratory, reminded.

The characteristic signs of the disease are motor disorders, decreased sensitivity, fatigue, numbness in the arms and legs, and visual impairment, she noted. Also, according to the doctor, with a long history of the disease, areas of the brain that are responsible for mental activity may suffer, and problems with memory and concentration may occur.

таблетки
Photo: IZVESTIA/Andrey Erstrem

The drug with glatiramer acetate is included in the treatment regimens for patients with multiple sclerosis and is one of the drugs, but not the main one, of the so-called first line, Nikolai Shamalov, chief freelance neurologist at the Ministry of Health, told Izvestia.

"Among all patients who receive medications that alter the course of multiple sclerosis (MERS), about 70% receive first—line medications, and about 20% of them are with glatiramer acetate," he noted.

Now the first-line nutrition products are represented by various active ingredients. All of them are interchangeable, as they have approximately the same effect on the activity of the disease, concluded Nikolai Shamalov.

Переведено сервисом «Яндекс Переводчик»

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