Russian patients call on state to increase procurements of Biogen’s Spinraza

Representatives of Russian patent unions have sent an appeal to the Russian Scientific Center for Expertise of Medical Products to provide a protocol for the compliance of Lantesens, a drug for the treatment for spinal muscular atrophy (SMA), which is produced by the Russian drugmaker Generium, a copy of the original drug Spinraza (nusinersen) from US biotech Biogen (Nasdaq: BIIB), reports The Pharma Letter’s local correspondent.

The Russian generic from Generium appeared in April 2024 and caused mistrust among some families of patients. Thus, parents of children with SMA said before the appearance of Lantesens in open sources, they did not find any information about its development, nor data on clinical trials.

According to a recent report from Forbes Russia magazine, citing on the local SMA Family Assistance Foundation, the registration of a drug that had not passed trials became possible thanks to the RF Government Resolution No 593 of April 5, 2022, which was extended in May 2023, and allows registration of an orphan drug based on reports on the results of clinical trials of another drug with the same active ingredient.