Mother of treatment: Russia lacks a drug for autoimmune diseases
There is a shortage of medicines with the active ingredient infliximab in Russian medical institutions, they are prescribed for ankylosing spondylitis, rheumatoid arthritis and other autoimmune diseases. Izvestia was informed about the problem in several patient organizations. The drug is also practically unavailable in pharmacies, the editors were convinced. The reason for the situation is problems with the delivery of raw materials, the manufacturing company said. The information about when the drug will become available and for which patients its absence is critical is in the Izvestia article.
Where there is not enough medicine
The drug with the active ingredient infliximab has stopped being given out in Russian hospitals, patients with autoimmune diseases, including Ankylosing spondylitis and Crohn's diseases, told Izvestia. This information was confirmed by several patient organizations at once, but they asked not to specify their names. They noted that difficulties with the availability of the drug have been observed since the fall of 2024.
According to the State Register of Medicines, infliximab drugs in Russia were registered by the Russian companies Biocad and Pharmapark, as well as the Korean Celltrion and the American MSD.
One of the patients, Alexey, told Izvestia that in October last year he contacted the Biocad company about the availability of the drug. In response to a request, he was informed that the drug was being produced as planned and an additional batch was expected to be released this half-year.
"Also, after the release of an additional batch, the drug will be available under the patient support program "Course for Recovery", implemented by our company. Currently, medicines with infliximab can be purchased in a limited list of partner pharmacies of the program where the drug is available," says Biocada's response dated October 2024.
But after that, the situation with the availability of the medicine did not improve.
For example, Sergei, a patient with Bekhterev's disease, told Izvestia that he had not received infliximab since February of this year.
— I was diagnosed in 2007, and I immediately started receiving infliximab. And in February, they told me that there was no drug and offered me two scenarios: take anti—inflammatory drugs to maintain remission and wait for the drug to appear on the market, or switch to a new one," he said. — But I was warned about the possible risk of non-acceptance of an alternative drug by the body and noted that after switching to another therapy, it would be impossible to return to taking infliximab. I've chosen the first tactic so far.
The analytical company RNC Pharma reported that 52 thousand packages of drugs with infliximab were launched on the market in 2024, which is 46% less than in 2023.
"96,000 packages were delivered in 2023, and about 70,000 packages in 2022," they added.
Also, the RNC noted, last year the main suppliers of medicines with infliximab were Pharmapark (37 thousand packages) and Biocad (about 15 thousand). The last deliveries of the drug produced by American MSD were in 2023.
According to another analytical company, DSM Group, the state segment received 59.36 thousand packages of drugs with infliximab in 2024, and 1.25 thousand packages in January 2025. Last year, only 190 packages of the drug were sold through pharmacies.
It is also difficult to buy drugs with infliximab in pharmacies now, the patients stressed. Although earlier, according to them, despite the lack of medicines in hospitals, it was possible to buy it there.
Izvestia analyzed data from pharmacy aggregators and found that infliximab drugs are currently unavailable in pharmacies in at least 69 regions. They can be purchased only in Moscow, St. Petersburg, Bashkiria and Tatarstan. But the patients warned that the information is not always reliable and before buying the drug you need to call or confirm its availability in person.
When will infliximab be available?
Izvestia sent requests to drug manufacturers asking them to clarify why there were interruptions in the delivery of the drug and when they are planned to be resolved.
"In the face of a difficult foreign policy environment and sanctions pressure, the company is doing everything possible to provide patients with the necessary therapy in a stable manner. Biocad has focused its efforts on the production of its own original drugs for the treatment of oncological and autoimmune diseases, as well as biosimilars produced and supplied primarily by the company," the company told Izvestia.
They noted that due to the sanctions restrictions, they revised "the models for providing production with certain types of raw materials necessary for the release of the drug infliximab, which led to forced changes in production processes and a shift in the production schedule of the drug." Biocade noted that they could not yet give an accurate forecast about the availability of the drug.
In addition, Biocade reported that it had notified the regulatory authorities of the temporary suspension of production of the drug to ensure its timely purchase from other manufacturers.
Izvestia sent requests to the Ministry of Health and the Ministry of Industry and Trade with a request to clarify whether they are aware of the difficulties with infliximab, why they might have arisen, how they are planned to be solved, as well as how many patients are currently being treated with the drug and whether it has analogues.
Currently, intravenous forms of genetically engineered biological drugs (GIBPS) are less common due to the greater convenience of subcutaneous or tablet forms for both the patient and medical staff, rheumatologist Alexander Elonakov told Izvestia.
"Infliximab treatment is continued by patients who were prescribed the drug in the first two decades of the century,— he added.
According to him, due to the shortage in the country, doctors will be forced to replace them with other drugs from the GIBP group when stocks run out.
— The choice of alternative medicines is quite large. But a change of therapy is allowed only for medical reasons. These include inefficiency, intolerance, and contraindications. When switching to other medications without these reasons, the disease may worsen and side effects may occur," the expert emphasized.
Irina Menshikova, Head of the Rheumatology Department at the I.M. Sechenov Clinical Center, noted that difficulties with infliximab would not affect patients with rheumatic diseases.
"We rarely use it in the hospital, we switched to more modern drugs," she said.
The situation that has arisen is more critical for patients with Crohn's disease, Irina Menshikova believes. With it, infliximab cannot be replaced with other medications.
Переведено сервисом «Яндекс Переводчик»
