Russia’s Axelpharm launches generic of AstraZeneca’s Tagrisso

Russian drugmaker Axelpharm has managed to lift the ban on the launch of osimertinib - a drug, which is used in the treatment of lung cancer - in the domestic market, reports The Pharma Letter’s local correspondent.

This is the result of the decision of Moscow Arbitration Court. The drug is a generic of the original Tagrisso from UK pharma major AstraZeneca (LSE: AZN). Earlier, the Russian antitrust regulator the Federal Antimonopoly Service (FAS) suspended sales of osimertinib in the Russian market, considering it a violation of the rights of the patent holder.

At the end of May 2025, the Moscow Arbitration Court, at the request of Axelpharm, overturned the ban imposed by the Federal Antimonopoly Service (FAS) on the launch of osimertinib into the Russian market. The FAS decision was preceded by an appeal, which was filled to the agency by AstraZeneca, which believed that its rights as the producer of the original drug Tagrisso were being violated. The original drug is localized in the Kaluga Region at the AstraZeneca’s production site in Russia. In the fall of 2024, the FAS agreed with the arguments of AstraZeneca, considering the actions of Axelpharm as a violation of competition and ordering it to pay 567 million roubles ($7.1 million) to the state budget.