Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid)
Shots:
- The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and NovoRapid, respectively, across all 30 EEA states
- Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.
- Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz will commercialize them in Europe and other key markets, while Gan & Lee will handle manufacturing and supply
Ref: Gan & Lee Pharmaceuticals | Image: Gan & Lee Pharmaceuticals | Press Release
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