The Russian Federal Antimonopoly Service (FAS) has established the price of the domestic generic version of the antitumor medication Tagrisso, which contains the active ingredient osimertinib. Its cost will be 50.3 thousand rubles, which is 40% less than the price for a package of the reference drug from AstraZeneca – 83.3 thousand rubles. This was reported in the FAS press service.
Axelpharm, the manufacturer of domestic osimertinib, successfully registered its drug in May 2023, despite the original medicine’s patent only expiring in the EAEU in 2032. According to the Ministry of Health and the Ministry of Industry and Trade of the Russian Federation, this measure is justified due to the potential risks of defects, thus necessitating the urgent release of a generic drug onto the market. The departments deny the possibility of an early release of the drug to the market in circumvention of the patent.
AstraZeneca tried to revoke the marketing authorization, but the court rejected the company’s demands. Moreover, in response, Axelpharm intends to obtain a compulsory license for the drug.
At the same time, Tagrisso is produced under a special investment contract in the Kaluga region in the required volumes. “There were no defects with this drug. Based on this, the introduction of a reproduced drug into civil circulation, including participation in government procurement, before the expiration of the patent for the original drug will be a violation of the legislation on the protection of intellectual property, which may negatively affect the availability of the drug for patients. In addition, there is no information about the possibilities of producing the drug by Axelpharm,” AstraZeneca commented on the situation.
