The Ministry of Health withdrew the registration of two drugs for the treatment of blood cancer
In the Russian Federation, registration of two drugs for the treatment of blood cancer is withdrawn-Revlimida and INNOVID, the rights to which belong to the Russian market of the American pharmaceutical company Bristol-Myers Squibb. Once these drugs were the best -selling public procurement in the segment, but now they are forced to give up the shares of Russian gentlemen. It is with this that the review by the American side of registration certificates for its drugs is associated.
The Ministry of Health withdrew the registration of two antitumor drugs used in therapy of patients with various types of blood cancer – Revlimida (the first registration certificate in the Russian Federation was received in 2009) and the Imnovid, whose sales in the country began in 2015. As follows from the data of the State Register of Medicines (GRLS), the registration of the Revalimide capsules from 2.5 mg to 25 mg and the INDOVID capsules with a dosage of 1 mg, 3 mg and 4 mg was canceled. There are no other forms of these drugs in the GRLS.
The rights to drugs with recalled licenses belonged to the American Bristol-Myers Squibb (BMS), in whose portfolio these funds appeared after the purchase of the business owner of the Celgene patents in the United States in 2019. BMS has become one of the few Western pharmaceutical companies who announced leaving the Russian market after the start of a military conflict between the Russian Federation and Ukraine (See “Kommersant” dated May 19, 2022).
Then BMS transferred the management of its business in the Russian Federation of the Swiss Swixx Healthcare AG, whose Russian “daughter” “Swix Hels” filed applications for the recall of licenses for Revlimid and Imnov. In Russia, the release of these drugs was localized. They were produced at two sites of Farmstandart-Elcest OJSC-in Kursk and in Ufa. In the Russian office, SWIXX Healthcare AG did not respond to Kommersant’s request.
The active substance « Revlimida » – Lenalidomide, « Immovid » – Limalidomide. There are 17 trading names of drugs with Lenalidomide and 9 in the GRLS – with permaleidomide. The oncologist Polina Shilo explains that drugs based on Lenalidomide are used to treat patients with multiple myeloma, smoldering myelo and myelodisplastic syndrome. Pomaleidomid is also used to treat multiple myeloma, as well as in the treatment of Kaposhi sarcoma.
Preparations with such active substances are implemented mainly as part of public procurement, while in recent years, state orders almost did not buy original drugs, preferring generics.
So, according to the public procurement website, the last application, which mentioned Revlimid, dates from January 2024. The Imnov was purchased at the auction for the last time in the summer of 2021.
According to the results of 2024 and the first two months of 2025, original drugs finally lost the market to generics. According to the analytical company DSM Group, in 2024, as part of public procurement, the following Lenalidomide preparations were acquired: Myelniks from Pharmo-Synthesis, Lenalidomide from Nanofarm Development, Hetero Labs, Ozon Medica and Pharmacintesis, Mulmilida from Mulmilida from Veropharma, Landotex, produced by Rafarma and Rupsulimid, produced by Biocad. For the whole of 2024, state institutions purchased 69.3 thousand packs of these drugs for 2.6 billion rubles, in January – February 2025 – 3.2 thousand packs for 70 million rubles.
Among the preparations with permalidomid, as part of the state-owned state, the “Pramaledomid” was purchased from Farmstandart, Imatango from Rafarma, Milodes from Pharmasintes-Nord, Polydover from Veropharma and Malidolix from Pharmo-Synthesis. In 2024, 13.2 thousand packages of such drugs for 1.9 billion rubles were sold as part of public procurement, in the first two months of 2025 – 849 packs for 13.2 million rubles.
Revlimid, once one of the best -selling in the world and expensive drugs, began to lose positions in the Russian market several years ago. In 2016, it was included in the state program “14 highly cost nosologies”. However, according to the results of a series of auctions that took place in May 2022, the drug was not purchased, although its suppliers submitted applications for at least three auctions. Then they were rejected on the “third extra” principle: applications from foreign companies are cut off if two or more Russian manufacturers also participate in the auction. Then, the Gostorgs purchased generics from Russian companies, and the price of auctions was 2-2.5 times lower than the previous tenders. The admission of Russian manufacturers for bidding then became possible due to the expiration of the patent for « Revlimid » (see “Kommersant” dated May 26, 2022).
