The Russian biotech company Biocad has received a registration certificate for spinal muscular atrophy drug nusinersen, according to the data included in the State Register of Medicines (GRLS). The medicine received the trade name Nusilara. The original drug was developed by the American biopharmaceutical company Biogen. There is also an analog of nucinersen marketed in Russia as Lantesens. It was registered by Generium.
A record of registration of nusinersen manufactured by Biocad in the GRLS appeared on April 4, 2025. All stages of production take place at the manufacturer’s site in Zelenograd.
Nusinersen is a spinal muscular atrophy drug. Biogen registered the drug under the trade name Spinaraza in 2019, and in 2020, it was included in the list of VED. In April 2024, the Russian company Generium registered a generic version of Nusinersen. In May, the maximum price was set at 3.85 million rubles, which is 25% cheaper than for the original drug, which has the registered price of 5.13 million rubles per package (excluding VAT).
In August 2024, Biogen announced that it intended to challenge the launch of a Russian generic of its expensive drug. The lawsuit against the Russian pharmaceutical manufacturer was filed jointly with the American research organization Cold Spring Harbor Laboratory. According to the plaintiffs, Generium violated one of the patents for Spinraza held by the American side.
SMA is a rare genetic disease that results in the development of progressive muscle weakness. It occurs due to a mutation of the SMN1 gene, which leads to a malfunction of the motor neurons of the spinal cord, special cells responsible for transmitting signals from the nervous system to the muscles. As a result, the extremities lose their strength. Due to the fact that muscles lose connection with nerve cells, patients suffer from muscle hypotrophy. The disease is also characterized by skeletal disorders (scoliosis, chest deformities), as well as contractures and respiratory failure that develop due to limited joint mobility.
