The Russian Ministry of Health has registered the drug “Diplam” (risdiplam) produced by the Indian company Jodas Expoim. Only one drug containing this component, the original “Evrysdi” from Roche, has been available in Russia since 2020 for treating spinal muscular atrophy. Risdiplam is under Roche’s Eurasian patent until November 2035 and is listed as a vital and essential drug.
At the moment, the cost of the original drug is 605.6 thousand rubles, while the price of the new generic has not yet been determined. The production process will be organized as follows: pharmaceutical raw materials (risdiplam) will be supplied by the Indian company Sumar Biotech, and Jodas Expoim, being the holder of the registration certificate, will undertake the production of the finished form of the drug, its packaging and quality control of the final product.
The new drug “Diplam” will be supplied in a concentration of 0.75 mg/ml in 2 g vials. The kit will include a special adapter and four syringes for oral use, packed in a cardboard box.