Suppliers reported reduction in import of immunoglobulin for pregnant women

Supplies of anti-Rhesus immunoglobulin, which is needed for pregnant women with a negative Rh factor, have significantly decreased compared to last year. Two of the four largest suppliers of the drug to the Russian market reported to RBC that there were no supplies in the first half of this year.

In the first half of 2024, the market received about 48 thousand packages, which is 71% lower than the same period in 2023, according to calculations by experts from the analytical company RNC Pharma. The current deficit is due to the lack of sufficient supplies, the company's development DIRECTOR Nikolai Bespalov explained to RBC.

In total, six anti-Rhesus immunoglobulin preparations are registered in RUSSIA, but the market is formed by four, three of which are produced abroad.

Almost half of the market (49.2%) in 2023 was occupied by the drug "Immunoro Kedrion", which is produced by the Italian company Kedrion Biopharm. In second place is the drug "Kamrou" from the Israeli company Kamada - 32.5%, another 14% was supplied by the international company CSL Behring - the manufacturer of the drug "Rezogam N". The remaining approximately 4.3% of the market was accounted for by the Russian drug, which is produced by the Ivanovo Regional Blood Transfusion Station.

Human anti-Rhesus immunoglobulin Rho[D] or anti-Rhesus immunoglobulin is obtained from donated human blood plasma. it is used in the treatment of Rh-negative patients after transfusion of incompatible Rh-positive blood or other products containing red blood cells.

In addition, anti-Rhesus immunoglobulin is necessary for women with a Rh-negative blood group and those pregnant with a Rh-positive fetus.

According to statistics, Rh sensitization (a conflict between the mother's immune system and the fetus's red blood cells) occurs in 1-1.5% of pregnant women, Tatyana Semenova, an obstetrician-gynecologist and HEAD of the transfusion therapy department at the Lapino Clinical Hospital of the Mother and Child Group of Companies, told RBC. According to her, in a certain percentage of cases, the fetus's red blood cells penetrate the mother's blood and antibodies are formed. If the mother formed antibodies during her first pregnancy, then in the absence of appropriate prevention, the titer of these antibodies may increase in the next pregnancy and lead to serious consequences for the fetus, including its death.

Kedrion Biopharm told RBC that the drug Immunoro Kedrion is “in limited availability,” and its next delivery is scheduled for the fourth quarter of 2024, but may be produced earlier, in September. The main reason for the non-deliveries in the first half of this year is due to insufficient availability of hyperimmune plasma, which is necessary for the production of immunoglobulin, the Italian supplier said. “This shortage has led to a significant decrease in the availability of the final product and an increase in production costs. The shortage of the product is typical not only for Russia,” the company emphasized. It also reported that in countries where the drug is still available, for example in the United States , its prices are significantly higher than in Russia and are more in line with the increased production costs.

The second largest drug in the market in 2023, Camrou, was supplied by the pharmaceutical company MIC (Medical Research Company LLC). As Sergey Zhukovsky, founder of Genfa Global (which owns 10% of MIC), told RBC, the manufacturer of the drug terminated the contract with the distributor in 2023, when the last delivery took place. Sales of Camrou continued until the first quarter of 2024, until the drug ran out. As Zhukovsky indicated, the manufacturer explained the termination of the contract by a global increase in the price of the original blood plasma, which is the basis of the drug, as well as the low registered price of the drug in Russia.

RBC sent a request to CSL Behring, but they had not responded at the time of publication.

The Ivanovo Regional Blood Transfusion Station (IRBS) did not respond to RBC's request to say whether there were any problems with the release of the drug. A representative of the manufacturer only said that one batch of the drug has been introduced into civilian circulation, and two more are in the drug quality control laboratory.

As of the end of July, Roszdravnadzor had not received letters about the planned cessation of supplies from suppliers or importers of anti-Rhesus immunoglobulin, the press service of the Ministry of HEALTH reported to RBC.

According to the state registry, in February of this year, the Ministry of Health registered a new price for the drug "Immunoro Kedrion". The agency did this according to the procedure provided in case of a drug shortage or its prevention. The cost of the drug almost doubled - from 2712.86 to 4290.18 rubles. "That is why the drug will appear on the market again in the fourth quarter of 2024," Kedrion Biopharm clarified. They also added that they plan to significantly increase supplies of the drug in the second half of 2025.

The Ministry of Health also sent a proposal to the Institute of the Society of the Prevention of the Diseases of the Russian Federation to re-register the maximum selling price for human immunoglobulin anti-Rhesus Rho (D), which the station produces, the Ministry indicated.

According to the CRPT drug flow monitoring system, as of August 5, there were more than 65,000 packages of anti-Rhesus immunoglobulin remaining in the country, the press service of the Ministry of Industry and Trade indicated. According to Bespalov from RNC Pharma, the annual need for the drug is approximately 200-210,000 packages per year. The existing stocks will last for about one quarter, he points out, not ruling out adverse consequences if supplies are not resumed in the coming months.

Previously, experts indicated that the release of immunoglobulin drugs could have been affected by the covid-19 pandemic , during which the collection of blood plasma was significantly reduced. Kedrion told RBC that the spread of COVID-19 led to a 30% decrease in the number of donors from 2019 to 2022, and the total volume of collected plasma needed to produce anti-Rhesus immunoglobulin decreased by 41% during this period.

In 2021, the Ministry of Industry and Trade reported that the agency periodically received information about shortages of various types of immunoglobulins in Russian regions. At the same time, the ministry notified Roszdravnadzor about the "risk of shortages" of drugs due to the low maximum selling price at auctions. Last year, some immunoglobulins were included in the list of drugs that could potentially be in short supply, but anti-Rhesus immunoglobulin was not on it.