Biologist Alexey Diashev, who previously directed the Binar Research Institute of the Russian Academy of Medical and Technical Sciences, discussed with Reedus the prospects of a Russian analogue to Spinraza, the drug known internationally as nusinersen for spinal muscular atrophy. The central question is whether a domestic version can fully replace the original. The expert did not dispute the drug’s quality, but he pointed to a less obvious problem that could affect accessibility and consistency.
He noted that drug development often occurs in a single research center. A team may develop and refine a compound within a limited base, rather than in large-scale, mass production. The laboratory can produce a highly purified, high-quality product, but once the project shifts to mass production, the integrity of the product can hinge on the conscience and practices of the broader manufacturing team. This is where the transition from prototype to commercial batches can introduce variability, according to Diashev.
Publications have cited the price gap between the original Spinraza and its Russian alternatives. A single pack of Spinraza, produced in Russia under the U.S. pharmaceutical company Biogen, reportedly costs about 5.13 million rubles. The Russian developer has argued that its analogue could be offered at a lower price, improving access for patients and health care systems alike. This pricing tension underscores the broader debate about domestic biopharmaceutical manufacturing, regulatory oversight, and patient affordability.
Reports from Vedomosti indicate that the Russian biotechnology company Generium will manufacture a domestic analogue of Spinraza labeled Lantesens. The drug’s registration details were published in the State Pharmaceutical Register (GRLS) of the Ministry of Health on April 15, signaling a formal step toward market entry and national production capability.
Additionally, the Russian government announced in December 2023 that the pharmaceutical company Geropharm received a compulsory license for the drug Semavik, an analogue of the Danish medication Ozempic. This move reflects a broader strategy to expand local manufacturing capacity for important therapeutic agents and to diversify supply chains within the country’s pharmaceutical sector.
These developments raise the question of why Russia pursues multiple forms and versions of critical medicines. Advocates argue that a diversified portfolio of domestically produced therapies can enhance national resilience, reduce dependence on foreign suppliers, and potentially lower long-term costs for the health system. Critics, however, caution about the challenges of ensuring consistent quality, robust pharmacovigilance, and reliable distribution networks across a large geographic area. The dialogue around Spinraza and its Russian counterparts continues to unfold as regulators, manufacturers, clinicians, and patient groups assess the best path forward for access to life-saving therapies. Attribution: Vedomosti and official regulatory disclosures; industry sources.