Russia’s Federal Antimonopoly Service (FAS) has sided with domestic drugmaker Biocad, ordering AstraZeneca to stop actions it said violated competition law.
Russia’s antitrust watchdog said AstraZeneca Pharmaceuticals, the company’s local unit, has complied with an official warning to halt alleged anti-competitive conduct, according to the FAS press service.
In February 2025, Biocad received approval from Russia’s Health Ministry to begin clinical trials of BCD-267, a generic drug for breast cancer. BCD-267 is an analog of Enhertu (trastuzumab deruxtecan), a cancer medicine registered by AstraZeneca.
After the approval, AstraZeneca sent a letter to Russian Health Minister Mikhail Murashko asking for the trial authorization to be suspended, citing “potential risks to the life and health of participants.” The company argued that the generic had not proven structural and biological equivalence to the original drug and said Russia lacks a clear regulatory framework for registering ADC-class (antibody–drug conjugates) medicines.
Biocad later filed a lawsuit in the Moscow Arbitration Court, accusing AstraZeneca of spreading false information about the trastuzumab deruxtecan analog. Biocad said the actions harmed its business reputation and threatened to derail the clinical trials.
FAS said it issued a warning to AstraZeneca Pharmaceuticals over signs of a violation of Russia’s competition law. As a result, the company stopped sharing information about alleged risks linked to BCD-267’s clinical trials, withdrew its earlier letters and publicly corrected the claims, and reported compliance within the required timeframe.
Source: Pharmvestnik
