Regulatory Action in Russia Involving Akrikhin and a Competing Diabetes Drug

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Russia’s Federal Antimonopoly Service is pursuing a case against the pharmaceutical company Akrikhin, alleging violations of the country’s competition laws. The information comes from an official directive issued by the agency’s head, Maxim Shaskolsky, and reported by RBC. The action highlights how competition oversight bodies respond when patent and licensing questions intersect with market entry plans in the pharmaceutical sector. Attribution: FAS directive, 2024.

In April 2024, Akrikhin released 22 batches of a diabetes treatment named Fordiglyf. This medication is positioned as a biosimilar or analogue to Forxiga, a drug originally developed by AstraZeneca, a British-Swedish firm. AstraZeneca asserts that Akrikhin’s distribution of Fordiglyf constitutes patent infringement, claiming the relevant patent remains valid until 2028. The dispute centers on whether the new product overlaps with the protected technology and, if so, whether such overlap constitutes unlawful competition under Russian law. Source note: AstraZeneca patent claim and dates.

AstraZeneca has framed the patent issue as one that could affect public health by potentially hindering access to legitimate, innovative medicines. The company’s stance emphasizes that safeguarding innovation supports longer, healthier lives and helps attract investment into new research and development. From AstraZeneca’s perspective, enforcing patent protections is a critical mechanism to prevent market confusion, protect clinical quality, and ensure that ongoing improvements in diabetes care can be funded and scaled for patients who need them. The company views the FAS case as a potentially important reference point for the industry, signaling that patent respect is essential for a stable, innovation-driven market. Industry commentary: public health and innovation incentives.

Earlier, AstraZeneca took additional steps by seeking action from the Investigative Committee related to its diabetes treatment. The sequence of formal regulatory actions reflects a broader pattern in the pharmaceutical landscape, where intellectual property, regulatory compliance, and competition rules intersect to shape the availability of treatment options for patients. Regulatory escalation noted by AstraZeneca and oversight bodies.

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