Sandoz has received European Commission marketing authorization for two rapid‑acting biosimilar insulins, Bysumlog (insulin lispro) and Dazparda (insulin aspart), reinforcing its strategy to expand access to affordable diabetes treatments across Europe. The products, developed by Gan & Lee Pharmaceuticals and supplied in prefilled injection pens, are authorized for use in diabetes mellitus across all indications of their respective reference medicines, Humalog and NovoRapid.
Bysumlog is approved for the treatment and initial stabilization of diabetes mellitus in adults and children. Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents, and children aged one year or older. According to Sandoz, both biosimilar insulins demonstrate equivalent efficacy and comparable safety to their originator products, positioning them to increase competition, improve affordability, and broaden access to insulin options for millions of people living with diabetes in Europe.
The latest approvals build on Sandoz’s growing diabetes portfolio, following the European Commission’s green light for Ondibta (insulin glargine) in January 2026. Together, Bysumlog, Dazparda, and Ondibta are intended to create a comprehensive biosimilar insulin offering spanning key rapid‑acting and basal insulin classes.
“Diabetes and its complications can devastate the lives of patients and their families and the disease is placing growing strain on healthcare systems across Europe,” said Armin Metzger, President Biosimilar Development, Manufacturing and Supply at Sandoz. He noted that, as prevalence continues to rise, high‑quality, affordable treatments are urgently needed, and that the approvals of Bysumlog and Dazparda, alongside Ondibta, represent “a meaningful step” in expanding access to vital insulins and in advancing sustainable access to life‑enhancing biosimilars.
Sandoz and Gan & Lee have been collaborating on biosimilar insulins since an agreement signed in December 2018 covering aspart, lispro, and glargine. Under the deal, Sandoz is responsible for commercialization in Europe and other key territories worldwide, while Gan & Lee oversees development, manufacturing, and supply.
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