MSD will no longer supply and manufacture the original drug isentress in Russia

The appearance on the Russian market at once of three generics based on raltegravir, prescribed to patients with HIV, forced the American pharmaceutical manufacturer MSD to stop deliveries and production of isentress in the Russian Federation. The annual volume of public procurement of medicines reached 5 billion rubles. With the advent of analogues, operators of state tenders can purchase them much cheaper. But the output volumes of Russian companies are still insufficient, experts warn.

MSD will no longer supply and manufacture the original raltegravir-based Isentress drug for adult patients in Russia, a Kommersant source on the market told Kommersant. Roszdravnadzor confirmed that the “daughter” of MSD “MSD Pharmaceuticals” notified the service of such plans. MSD and R-Pharma (engaged in the packaging of funds in the Russian Federation) did not respond to Kommersant’s request.

Antiretroviral (ARV) drugs in the Russian Federation are provided to HIV-infected people free of charge and are purchased centrally by the Ministry of Health, while regions purchase part of the volumes separately. Raltegravir is one of the most expensive drugs in this segment. According to the Zdravresurs expert group, in 2022, this drug in an adult dosage accounted for 12% of all public procurement of ARV drugs, or 4.89 billion rubles.

MSD’s decision coincided with the launch of a number of Russian generics of raltegravir, as the patent protection for the main substance, which was assigned to the American manufacturer, expired in October 2022. So, since the end of 2022, Promomed (rolnavir), Pharmasyntez (raltegra) and PSK Pharma (raltegravir PSK) have brought their drugs to the market. These companies registered the same marginal price for their generics – 34% lower than the cost of the original isentress (12.5 thousand rubles with VAT for 60 tablets).

With the release of generics, Isentress has become rarely supplied by government order, follows from Headway Company data. In the first half of the year, the regions purchased this drug for 10.2 million rubles, and its generics – for 118.1 million rubles. The price of analogues in 2023 in regional purchases decreased: for example, Moscow purchased the drug six times cheaper than the cost of the original – for 2.87 thousand rubles, says Natalya Egorova, an analyst at Zdravresurs.

The Ministry of Health purchased the main volume of isentress immediately for three years back in 2021, before the release of generics. Then the contract for the supply of isentress for 13.54 billion rubles. signed with R-Pharm. In February of this year, the NPO NCPH approached the Ministry of Health with a proposal to negotiate a price reduction with MSD due to the loss of patent protection, Pharmvestnik reported, but this did not happen. R-Pharm supplies isentress under the contract in accordance with the schedule, Kommersant was told at the Ministry of Health. Nevertheless, this summer, the ministry has twice bought more generics of raltegravir from Primafarm at a price one third cheaper.

At the same time, under the largest contract for 195 million rubles. Generics from three manufacturers will be supplied at once. According to Natalya Egorova, this may be due to the fact that none of the Russian companies yet has enough substance or capacity to produce the drug in the required quantity. In the first half of the year, Pharmasyntez and Promomed produced a total of 26.3 thousand packs of raltegravir with an annual need of about 300 thousand packs, calculated at RNC Pharma. Given that raltegravir is produced in a relatively simple form of release (tablets), companies can easily provide the required volumes in two to five months, says Nikolay Bespalov, director of development of the company.

Evgenia Shapiro, General Director of PSK Pharma, claims that the company has enough opportunities and capacities to fully meet the needs of patients with HIV in raltegravir. Promomed says that they are “actively working on increasing the production” of their medicine. Pharmasyntez did not respond to Kommersant’s request. Other suppliers were also interested in the drug, recalls Mr. Bespalov. In addition to the three companies mentioned above, ten more companies received permits for its clinical trials in 2021-2023, including R-Pharm, the Russian partner of MSD.

Polina Gritsenko