Why the study?
To evaluate the biological activity of generic risdiplam (Vapromin) and compare it with the reference drug Evrysdi across different batches.
Population
Fibroblasts from three SMA patients and a constructed reporter cell line
Comparison
Generic risdiplam (Vapromin) vs reference drug (Evrysdi)
Design
In vitro comparative study
Key result
In vitro treatment with generic risdiplam (Vapromin) demonstrated comparable biological activity to the reference drug (Evrysdi), with both achieving a 2.5-fold increase in SMN2 full-length transcripts.
Authors
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Generic risdiplam demonstrates comparable in vitro splicing activity; leaves open clinical bioequivalence and batch interchangeability in SMA.
The in vitro biological activity of the generic risdiplam Vapromin is comparable to the reference drug Evrysdi in SMA patient-derived fibroblasts and reporter cell lines.
Strizhakova et al. (2026) studied Spinal muscular atrophy (SMA) (n=3). Vapromin (generic risdiplam) vs. Evrysdi (reference risdiplam) was evaluated on Relative transcription level of SMN2 mRNA and SMN protein production. In vitro treatment with generic risdiplam (Vapromin) demonstrated comparable biological activity to the reference drug (Evrysdi), with both achieving a 2.5-fold increase in SMN2 full-length transcripts.