Sandoz received European Commission approval for Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), two biosimilar rapid-acting insulin analogues developed with Gan & Lee Pharmaceuticals, expanding access to affordable diabetes treatments across Europe.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Sandoz announced that the European Commission (EC) has granted marketing authorization for Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), two biosimilar rapid-acting insulin analogues developed in partnership with Gan & Lee Pharmaceuticals. The authorizations strengthen Sandoz’s diabetes and biosimilars portfolio across Europe while expanding patient access to more affordable insulin therapies.
The approvals follow positive recommendations previously issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Granted through the European Union centralized regulatory procedure, the authorizations are automatically valid across all EU member states as well as European Economic Area (EEA) countries including Iceland, Liechtenstein, and Norway.
Bysumlog® is a biosimilar to Eli Lilly’s Humalog® (insulin lispro), while Dazparda® references Novo Nordisk’s NovoRapid®/NovoLog® (insulin aspart). Both products are approved for use in adults and pediatric patients with diabetes mellitus requiring insulin therapy for glycemic control and will be available as 100 units/mL pre-filled disposable injection pens. Rapid-acting insulin analogues are typically administered around mealtimes to help control postprandial blood glucose levels.
The EC authorizations were supported by extensive analytical comparability assessments together with pharmacokinetic (PK) and pharmacodynamic (PD) studies confirming biosimilarity to the respective reference insulin products. The submitted data demonstrated no clinically meaningful differences in efficacy, safety, immunogenicity, or tolerability compared with the originator therapies.
A randomized, double-blind Phase I study conducted in Europe demonstrated comparable pharmacokinetic and pharmacodynamic profiles between Bysumlog® and reference insulin lispro. Comparable analytical and clinical evidence also supported the authorization of Dazparda®, supporting the quality, safety, and clinical performance of both biosimilar insulin therapies.
The regulatory clearances come amid rising diabetes prevalence and increasing pressure on European healthcare systems to improve access to cost-effective insulin treatments. According to the International Diabetes Federation (IDF) Diabetes Atlas 2025, approximately 65.6 million adults aged 20–79 years are currently living with diabetes across Europe. Diabetes-related healthcare expenditure in the region is projected to approach USD 200 billion annually, underscoring the growing demand for sustainable and affordable therapeutic options.
The EC decision also represents an important commercial milestone for Sandoz. In the first quarter of 2026, the company reported 18% year-over-year growth in biosimilars sales, driven by continued expansion of its biologics portfolio and increasing global adoption of biosimilar medicines.
Armin Metzger, President Biosimilar Development, Manufacturing and Supply at Sandoz, said the approvals of Bysumlog® and Dazparda®, alongside Ondibta earlier this year, mark an important step toward expanding access to high-quality and affordable insulin therapies across Europe amid the rising burden of diabetes.
Under a previously established commercialization and supply agreement, Gan & Lee is responsible for manufacturing and supply operations, while Sandoz retains commercialization rights for insulin glargine, insulin lispro, and insulin aspart biosimilars across Europe and selected international markets.
The addition of Bysumlog® and Dazparda® expands Sandoz’s diabetes biosimilars portfolio and may help improve long-term access to cost-effective insulin therapies across Europe. Commercial launch timelines have not yet been disclosed.
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About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.
