The Russian Ministry of Health has approved a generic version of risdiplam, an orphan drug for the treatment of spinal muscular atrophy (SMA), according to the data from the State Register of Medicines (GRLS). The registration certificate for the drug was issued to the Russian biopharmaceutical company Promomed. The trade name of the drug coincides with the INN, Risdiplam.
The drug’s registration certificate issued under the rules of the Eurasian Economic Union (EAEU) is valid until 2030. The manufacturer of the finished dosage form is AO Biokhimik.
In 2024, the Ministry of Health of the Russian Federation registered Diplam (risdiplam) produced by the Indian company Jodas Expoim. Up to this point, only one drug with this INN was available in Russia, the original Roche’s Evrysdi, which has been used as oral SMA therapy since 2020. In the same year, it received orphan drug status.
Risdiplam is protected by Roche’s Eurasian patent until November 2035. It is included in the list of vital and essential drugs (VED).
In April, it became known that the Ministry of Health had suspended the registration certificates for eight Jodas Expoim medicines, including Diplam. In February, it was reported that the Ministry suspended the circulation of a number of medicines of the Indian company.
On May 14, the first hearing on the Geropharma and Roche patent dispute between was held at the Moscow Commercial (Arbitrazh) Court. The Russian manufacturer filed a lawsuit against the Swiss company, the American PTC Therapeutics and Rospatent in March 2025. The reason was the risk of risdiplam shortage. The company said it had received an official refusal from Roche to grant a voluntary license.
