NPO Microgen, a company of the Natsimbio holding (part of the Rostec State Corporation), is launching the first domestic human normal immunoglobulin for intravenous administration in the form of a 10% solution. On December 5, a registration certificate for the new drug was issued by the Ministry of Health of Russia. This was reported in the Rostec’s press service.
“The new product will substitute for its foreign analogues available on the market and increase the availability and quality of therapy for patients with immunodeficiency conditions. The drug, which received the trade name BioGam, is administered intravenously as a replacement and immunomodulatory therapy in patients with reduced or absent antibody response. The introduction of an immunoglobulin solution will compensate for the deficiency and increase the level of antibodies to optimal physiological values and, thus, reduce the risk of infections in patients,” the message reads.
Similar drugs are used in other countries for the treatment of congenital and acquired immunodeficiency, e.g., in HIV infection, Guillain-Barré syndrome, Kawasaki disease, for the treatment and prevention of infectious diseases, as well as in organ transplantation, the press service stressed.
“Natsimbio is the first among Russian companies to market an intravenous immunoglobulin drug in a 10% concentration. Such drugs are crucial for the quality of life of patients with immunodeficiency. Their main difference is that with high concentrations, optimal results in therapy can be achieved with smaller volumes of the drug and in less time. This is especially important for pediatric practice, therapy of pregnant women, patients with cardiovascular diseases and renal pathology,” said Andrey Zagorsky, Natsimbio’s CEO.
The immunoglobulin, BioGam, belongs to the most recent (fourth) generation of immunoglobulins, which are produced with the use of chromatographic purification and some extra stages of virus inactivation. The technological specifics also make it possible to accelerate the introduction of the drug into civil circulation due to a significantly shorter production time, Rostec said.
The registration certificate for the drug was obtained under the accelerated procedure for registration of medicines established by the Decree of the Government of the Russian Federation No. 593 dated April 5, 2022. BioGam has successfully passed the first phase of clinical trials, where its safety and high tolerability were confirned. The second and third phases are currently underway. The production of normal human immunoglobulin will be organized as full-cycle manufacturing at a site in Perm, the state corporation added.