Bioequivalence between Spinraza and its generic version, GNR-100, has been demonstrated in SMA

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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.

 

Comparative Characterization of a Proposed Generic Nusinersen: Identity of the Oligonucleotide Structure and Equivalence in SMN2 Splicing Activity. Taran S, Smolov M, Degterev M et al. Pharmaceutics. 2026 Jan.

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