Fabagal® for Fabry disease management is now available in Russia

The medication support for Russian patients with the rare Fabry disease is becoming more affordable. This fall already, Petrovax Pharm is launching to the market a new drug, Fabagal®, the first biosimilar of agalsidase beta in Russia. On September 28, the Ministry of Health of the Russian Federation, by agreement with the FAS, registered the maximum selling price for Fabagal®[1] — 110,980 RUB per vial, which is 40% lower than the registered price for the similar original drug.

The launch of Fabagal® on the Russian market will support significantly more patients in need for the treatment at the expense of budgetary funds.

The localization of this pharmaceutical product is the large investment project of Petrovax Pharm being implemented by the Russian pharmaceutical manufacturer in partnership with the South Korean company ISU Abxis. In August, Petrovax secured a marketing authorization[2] for a full-cycle production of Fabagal® in Russia from 2024, including the substance. Until that time, Petrovax plans to import Fabagal® to Russia — the first deliveries are expected in October this year.

Fabagal® (agalsidase beta) is indicated for long-term enzyme replacement therapy in adults and children from 8 y.o. with Fabry disease. In this orphan genetically determined disease, kidney damage, neuropathic pain in the limbs, congestive heart failure, infarction and stroke are observed. In the lack of early diagnosis and properly selected treatment the disease leads to permanent disability and death.

State Register of Medicines https://grls.minzdrav.gov.ru/PriceLims.aspx?TradeName=%d0%a4%d0%b0%d0%b1%d0%b0%d0%b3%d0%b0%d0%bb&INN=&RegNumber=&OrgName=&Barcode=&OrderNumber=&OuterState=60&PageSize=&OrderBy=pklimprice&OrderType=desc


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