Russian pharmaceutical company Biocad has filed a lawsuit against AstraZeneca, accusing the British-Swedish pharmaceutical giant of unfair competition and attempts to disrupt clinical trials of its biosimilar to Enhertu, a drug used to treat aggressive forms of cancer.
The lawsuit, filed with the Moscow Arbitration Court against AstraZeneca Pharmaceuticals LLC (the legal entity representing AstraZeneca in Russia), was reported by Forbes Healthcare.
According to Biocad, AstraZeneca has been spreading false information about Biocad’s biosimilar of trastuzumab deruxtecan, known as BCD-267. Biocad claims the actions were aimed at damaging its business reputation and undermining ongoing clinical trials.
In April, the Russian Ministry of Health authorized Biocad to begin clinical trials of BCD-267. Shortly after, AstraZeneca sent a letter to Health Minister Mikhail Murashko, urging the ministry to suspend the trial authorization, citing “potential risks to the lives and health of participants.”
AstraZeneca argued that the structural and biological comparability of Biocad’s biosimilar to the original drug has not been proven, and that Russia lacks the regulatory framework for approving biosimilars of antibody-drug conjugates (ADCs) — targeted cancer therapies that link monoclonal antibodies with cytotoxic agents.
The company emphasized that even minor differences in the molecular structure of such complex drugs could impact safety or efficacy. AstraZeneca also pointed out that there is no global precedent for the registration of ADC biosimilars, and that current evaluation standards for monoclonal antibody biosimilars are insufficient for ADCs, due to their unique properties.
In response, Biocad criticized what it described as a typical tactic of certain foreign pharmaceutical companies, who “resort to informal pressure, legal roadblocks, and behind-the-scenes lobbying” rather than fair market competition.
“The criticism implies that the Ministry of Health and its expert institutions are incapable of evaluating complex drugs. Yet the original drug underwent the same regulatory scrutiny by the Ministry,”
said Alexey Kedrin, Chairman of the Board of the EAEU Association of Pharmaceutical Manufacturers, commenting on AstraZeneca’s actions.
According to the Russia State Register of Medicines (GRLS), Biocad began Phase I trials of its biosimilar in February 2025, with the study expected to run through 2031. A total of 252 patients are participating, across 42 hospitals.
Source: Forbes
