Reputation in vitro: biosimilar of cancer drug to be tested in reputation case

For more than a year, the dispute between AstraZeneca and BIOCAD has been going on, which concerns the protection of business reputation in connection with the discrediting of BCD-267, a biosimilar of the antitumor drug Enchertu developed by a Russian company. The FAS sided with BIOCAD, but as part of a counterclaim to protect business reputation from AstraZeneca, they suddenly demanded an expert examination, in fact, concerning the properties of the drug, and not the subject of the proceedings. Izvestia investigated how this would affect the ongoing clinical trials of the Russian drug and whether it would create a serious judicial precedent.

What will the forensic expert check?

The story of the confrontation between AstraZeneca and BIOCAD, concerning the Russian biosimilar of a drug intended for the treatment of certain types of breast and stomach cancers, began in 2025. In February 2025, the Ministry of Health of the Russian Federation authorized BIOCAD to conduct clinical trials of the drug BCD-267, which is a biosimilar of Enhertu (trastuzumab deruxtecan), and in April AstraZeneca sent letters to the Ministry of Health and clinics with warnings about "potential risks" for patients participating in the Russian drug. In response to these actions, BIOCAD filed a lawsuit to protect its business reputation against AstraZeneca, accusing the Russian company of discrediting the BCD—267 drug and undermining BIOCAD's reputation. In December 2025, the Federal Antimonopoly Service issued a warning to AstraZeneca about signs of violation of antimonopoly legislation. As a result, according to the FAS, "the company stopped distributing information about the risks associated with conducting clinical trials of the drug BCD-267, withdrew previously sent letters and refuted the information contained in them, and also reported on the implementation of the warning within the prescribed period."

Against this background, in the spring of 2026, BIOCAD dropped its lawsuit to protect its business reputation, but AstraZeneca insisted on continuing the case and demanded to consider its counterclaim, and with the appointment of a biosimilar forensic examination.

AstraZeneca's requirements were taken into account and a judicial examination was indeed ordered. In the case of protecting business reputation, they will check whether the drug is a biosimilar and whether it corresponds to the international nonproprietary name trastuzumab deruxtecan. Another question that the expert faces is what consequences for patients may arise when using this drug "due to differences" from the original drug.

The expert should draw these conclusions based on information about the composition of the investigational drug; a document from BIOCAD with characteristics and information about it produced for clinical trials; and data from the international patent application for the invention "Trastuzumab conjugate with a medicinal product".

Meanwhile, according to the experts interviewed by Izvestia, virtually all the answers to the questions can only be given by clinical trials that are already underway and are undergoing phase III.

Why was an examination of the molecule ordered in the reputation case?

The experts interviewed by Izvestia expressed their bewilderment at the fact that a definition was issued on the examination of biosimilarity in a reputational case.

For example, Taisiya Kubrina, Senior associate at the Pepelyaev Group Pharmacy and Healthcare Practice, stressed that business reputation cases are based on the dissemination of information that is untrue and discredits the good name of a company or product. The subject of consideration of such cases may be only statements about facts, but not evaluative opinions and judgments, and the controversial statement must contain a negative assessment of the activities of the other party and be false. In her opinion, depending on the content of the controversial statement, a forensic examination may be appointed to determine whether it relates to facts rather than assessments, whether it corresponds to reality or not.

Anna Zabrotskaya, Managing Partner of the Nordic Star Law Firm, noted that in this situation, the expert was instructed to conduct a scientific and regulatory assessment of the drug, rather than verify specific statements.

"But if the clinical data are not fully investigated, the conclusion about the consequences for patients will inevitably have limited evidentiary value and will be based primarily on molecular and documentary characteristics, rather than on a confirmed clinical safety profile of the drug," the source told Izvestia.

As Anna Zabrotskaya emphasizes, it follows from the court's ruling that the issues were eventually accepted in the wording of AstraZeneca and not adjusted, despite the objections of BIOCAD and the Ministry of Health. As a result, the examination shifted from the issue of business reputation to an assessment of the scientific viability of the drug as a whole.

Svetlana Zavidova, Executive Director of the Association of Clinical Research Organizations, notes that any expert's response at this stage will still not be final: clinical trials are underway now, and the Ministry of Health will make a decision based on the totality of all data. The expert will not have all the information.

— In fact, it looks like an attempt by a single expert decision to replace the decision of the regulatory authority, — said the interlocutor of Izvestia. — Probably, the expert will have to make only some assumptions on these issues.

Ravil Niyazov, a specialist in regulatory issues and drug development at the Scientific Advisory Center, noted that an expert in this situation can only say "general words" and point out the differences between the two drugs, which may differ in terms of safety and efficacy.

— Experts usually always proceed from the presumption of insecurity and inefficiency: that is, everything that has not been studied or differs is potentially unsafe or less effective until proven otherwise. As far as I know, BCD-267 is a deuterated product, and this may prevent confirmation of the biosimilarity of the original product and cause differences in safety and efficacy from the original product. But in which direction these differences will occur, probably no one will undertake to predict without conducting additional research," he told Izvestia.

He stressed that in order to establish biosimilarity, large-scale studies should first be carried out at the level of physico–chemical and functional properties - in vitro tests, when high comparability of the structure is confirmed, and it is confirmed that two molecules from different manufacturers are functionally comparable. All this is installed in in vitro models. This is a rather lengthy process, and it is often necessary to refine the production process at this stage. And only if this is confirmed on cells, receptors and tissues, then they proceed to clinical research. In many countries of the world, it is now sufficient to conduct only pharmacokinetic comparisons, and in Russia, studies are also required to compare efficacy and safety.

— In any case, only specialists who work in this field can assess biosimilarity, and only they can say how much two biomolecules differ from each other or are comparable. In my opinion, these issues should be addressed by the expert community," Ravil Niyazov said.

None of the experts interviewed are aware of cases where, in parallel with an ongoing clinical trial, the biosimilarity of the same drug is being proven as part of a lawsuit.

How will expertise affect clinical trials

Svetlana Zavidova emphasizes that the attempt to revoke the permission for clinical trials initially looked like a manifestation of unfair competition, and therefore the FAS issued a warning. She stressed that permits for clinical trials are issued for a reason, but on the basis of a fairly rigorous examination, including from the Ministry of Health.

Anna Zabrotskaya pointed out that neither the examination nor the suspension of proceedings in a reputational case by themselves affect the permission of the Ministry of Health to conduct a clinical trial.

— This is an independent regulatory procedure, and only the competent authority can suspend it in accordance with the procedure established by law. The expert opinion has no prejudicial significance for the FAS, Rospatent or the Ministry of Health: each of these bodies conducts its own assessment according to its own criteria," the source told Izvestia.

Industry experts are wondering whether the use of such legal instruments can replace regulatory processes with a private expert opinion based on incomplete data and artificially slow down the entry of domestic analogues into the market. And most importantly, how will this affect the development of import substitution in the strategically important healthcare sector.