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поиск по ресурсному центру On the website of the State Register of Medicinal Products a notice appeared on the cancellation abolition of the state registration of the Invirase drug (INN saquinavir).
The decision to cancel the state registration and to exclude the medication from the State Register of Medicinal Products was made by the Ministry of Health of the Russian Federation on the basis of a petition filed by the authorized legal entity F. Hoffmann-La Roche Ltd (Switzerland) on the cancellation of the state registration of the drug.
Invirase was approved by the US Food and Drug Administration (FDA) in 1995, it is the first drug of the HIV protease inhibitors class to enter the pharmaceutical market. In December 2003, the FDA approved the use of high doses of Invirase in combination with ritonavir.
The medication under trade name Invirase produced by Roche Pharma S.A. (Netherlands) was registered in the Russian Federation on 09.07.2007.
INN saquinavir is included in the List of Essential Medicines (LEM). The drug under a generic trade name “Interfast” manufactured by Pharmasynthesis JSC (Russia) is now included in the government procurement lists.
In 2018, the Ministry of Health of the Russian Federation purchased just over 4,000 annual courses for a total of 220 million rubles. The entire volume of the drug was purchased in the form of generic product.
The drug “Invirase” became another original ARV-drug after “Stocrin”, which was taken out of the Russian market in 2018. This may indicate that there is no competition between original and generic drugs in terms of price if generics are available, thus, only generics remain on the market. Taking into account the RF Government Resolution No. 1289 of 30.11.2015 with the so-called “no third party” rule, which imposes restrictions on government purchases of imported drugs from the LEM list, the original drugs have virtually no chance to be included in procurement lists provided that generics are available.
