GNR-100 could be the first generic version of Spinraza for SMN1-related proximal spinal muscular atrophy. A Russian study has demonstrated bioequivalence between the two products, both of which contain the active ingredient nusinersen sodium (an antisense oligonucleotide).
- Comparative analyses have shown that the structural and physicochemical properties of the two products are similar.
- The impurity profiles of the two medicines are also comparable.
- In vitro tests on patient fibroblasts showed an equivalent increase in the production of functional SMN protein.
Russia and Kazakhstan have authorised the marketing of GNR-100, following clinical trials that demonstrated its safety and efficacy, thereby confirming its bioequivalence. If authorised in France, this generic would provide low-cost access to nusinersen.
