American cancer drugs in Russia to be replaced by generics
Tatarstan cancer patients may have problems in case of individual intolerance to domestic drugs
The Russian subsidiary of the Swiss company Swixx Healthcare AG, Swixx Healthcare, has revoked its licences for the production of the antitumor drugs Revlimid and Imnovid used to treat blood cancer. In turn, the Russian Ministry of Health Care revoked the registration certificates of these drugs. Realnoe Vremya found out what this event could mean for patients suffering from cancer in Tatarstan clinics and whether the republic will face a shortage of drugs for the treatment of cancer.
The original medicine has become cheaper and left the market
The Russian subsidiary of the Swiss company Swixx Healthcare AG, Swixx Healthcare, has revoked the licences for the production of the drugs Realimid and Imnovid, which were received in 2009 and 2015, and the Russian Ministry of Health Care has revoked their registration certificates. According to the State Register of Medicines, this concerns Revlimid in capsules with a dosage of 2.5 to 25 mg and Imnovid with a dosage of 1.3 and 4 mg.
In Russia, these drugs were produced by two enterprises of Pharmstandard-Leksredstva located in Ufa and Kursk. According to SPARK-Interfax, the owner of the enterprises is the Russian Pharmstandard, which in the first quarter of 2017 (the date of the last disclosure of information) was more than 96% owned by the Cypriot Augment Invtstments Ltd., which ceased to exist in December 2023.
The copyright holder of Revlimid and Imnovid is the American company Bristol-Myers Squibb (BMS), which left the Russian market with the start of the special military operation in 2022. However, the drugs themselves remained in Russia: BMS transferred the management of the business in Russia to the Swiss company Swixx Healthcare AG, which registered a very profitable subsidiary in the Russian Federation — Swixx Healthcare LLC (the company's revenue in 2024 amounted to almost 23.4 billion rubles, and net profit — 441 million).
At the same time, back in 2023, the American lenalidomide (international name) lost its patent protection, after which the Russian Ministry of Health “dropped” its cost when concluding the largest state contract for public procurement by 200 times, and its average price fell by half.
Realnoe Vremya sent a request to Director of Svix Healthcare Pavel Chistyakov and the general director of Pharmstandard-Leksredstva about the fate of the production of original antitumor drugs in Russia. Upon receipt, the responses will be published.
“Patients in Tatarstan are provided with drugs”
“The drug Revlimid has the international nonproprietary name (INN) Lenalidomide, Imnovid — Pomalidomide,” Realnoe Vremya was told in the republican Ministry of Health Care. “As of 22 April 2025, drugs from 17 manufacturers are registered in the State Register of Medicines under the INN Lenalidomide, of which 14 are domestic manufacturers. Also, as of April 22, drugs from nine manufacturers are registered in the State Register of Medicines under the INN Pomalidomide, all of them are domestic.”
The ministry emphasized that all these drugs — generics — have been introduced into civil circulation, are available on the pharmaceutical market and have been supplied to the republic since 2022 as part of the federal program “14 high-cost nosologies.” And they assured that patients in Tatarstan are provided with drugs with the specified active ingredients.
“The original drug is the best”
At the same time, according to the expert, it is premature to say that the issue of replacing original American cancer drugs has already been resolved. Practice will show how effective this replacement is.
“There is no difference if the manufacturers work in good faith”
At the same time, he says, no one can still unravel the pathogenesis of the disease, and the drugs that are currently used in modern oncology, including Revlimid and Imnovid produced by an American pharmaceutical company, are palliative, i.e. they do not act selectively, pointwise on the pathogenesis of cancer.
“All anti-cancer drugs are usually toxic,” he noted. “They usually cause necrosis of cancer cells, damage healthy cells, microbiota and the immune system. For patients, there is no fundamental difference whether these drugs or their generics are used, but only on condition that our manufacturers work in good faith — observing the requirements for the purity of raw materials and the entire technological cycle of production.” Professor Kutyshov is a supporter of the use of non-toxic drugs of his own invention for the treatment of cancer patients, which, according to his theory, suppress the proliferation and metabolism of cancer cells. However, this theory has both followers and opponents.
“This company needs to be dealt with!”
“The registration of Realimid and Imnovid was revoked by the foreign manufacturer itself,” emphasized State Duma deputy from Tatarstan, former Minister of Health of the Republic Airat Farrakhov commenting on the situation to Realnoe Vremya. “In this situation, the first thing that is very good is that we have our own generics and they are just as effective. But I would like to understand why the company did this. They should explain this! Because an isolated situation may arise when a patient has an intolerance to generics, and then original drugs will be needed. And a problem may arise.”
The deputy believes that it is necessary to figure out whether the revocation of the registration of Realimid and Imnovid was an unfriendly act, which should be followed by punishment.
Airat Farrakhov emphasized that the state programs Pharma-2020 and Pharma-2023 have yielded results — Russia has received its own drugs and generics that work effectively and are cheaper than original drugs, which is very important. “Consequently, more patients will be able to receive this treatment than for free. Therefore, I do not see anything bad here,” he concluded.