Russia's FAS has agreed the price for generic of osimertinib, the patent rights to which belong to AstraZeneca. According to FAS, agreeing the price for generic osimertinib will increase the availability of the drug for patients.
The Federal Antimonopoly Service of Russia has agreed the maximum selling prices for AxelPharm's generic osimertinib, according to the service's decision database. The original drug under the brand name Tagrisso (Osimertinib) is produced by AstraZeneca, and it is still under patent. The drug is intended for the therapy of patients with lung cancer.
Thus, the cost of the generic in a dosage of 40 mg, 30 pcs. will amount to 151,025 rubles, in a dosage of 80 mg, 10 pcs. - 50,341.47 rubles, 80 mg, 30 pcs. - 151,664.66 rubles. This is 40% cheaper than the cost of the original drug, which in similar dosages is 250,000 rubles, 83,333 rubles and 251,058.87 rubles.
FAS claims that harmonization of prices for the first domestic generic of the drug will increase its availability for citizens. It should be provided free of charge in medical organizations under the program of state guarantees of free medical care.
The press service of AstraZeneca, in turn, pointed out that there was and is no deficiency of osimertinib. The drug is produced by the company in Russia on a full cycle under a special investment contract with the Ministry of Industry and Trade and the Kaluga region in volumes that fully meet the needs of the Russian market, the company also added.
While AxelPharm is going through the necessary registration procedures to bring its drug to the market, in parallel, the company is trying to obtain a compulsory license for its production through the court.
AstraZeneca also tried to cancel the registration of the generic through the court, but the claim was not satisfied. The original osimertinib is protected by Eurasian patent No. EA 024421, which will expire only in July 2032.
At that time the Ministry of Industry said that the analog of the drug was registered "to enable its prompt introduction to the market in case of risks of withdrawal of the original drug manufacturer from the Russian market". In addition, the ministry noted that the fact of registration of the drug is not an infringement of intellectual property rights, and the price of the generic is not registered.
Now, based on the FAS decision, the registration of the selling price for the drug is not long in coming.
Source: Pharmvestnik
