BASEL, Switzerland, May 15, 2026
Sandoz has announced that the European Commission (EC) granted marketing authorization for two biosimilar insulin products, Bysumlog® (insulin lispro) and Dazparda® (insulin aspart), significantly strengthening the company’s diabetes portfolio and expanding access to affordable insulin treatments across Europe. The approvals mark another major milestone for Sandoz in the rapidly growing biosimilars market and reinforce its long-term strategy of expanding access to high-quality biologic medicines for millions of diabetes patients.
The newly approved biosimilars are indicated for the treatment of diabetes mellitus across all approved indications of their respective reference medicines, Humalog® and NovoRapid®. According to Sandoz, both biosimilars demonstrated equivalent efficacy and comparable safety to the originator insulin therapies, supporting broader competition and affordability in the European diabetes market.
Biosimilar Insulins Aim to Expand Affordable Diabetes Care
The approvals come at a time when diabetes prevalence continues to rise sharply worldwide, placing enormous pressure on healthcare systems and increasing demand for lower-cost treatment alternatives. Sandoz stated that approximately 66 million adults in Europe currently live with diabetes, with the number expected to rise to 72 million by 2050, while diabetes-related healthcare spending could approach USD 200 billion.
Bysumlog®, a biosimilar version of insulin lispro, is approved for the treatment and stabilization of diabetes mellitus in both adults and children. The rapid-acting insulin analogue begins working within 10 to 15 minutes after subcutaneous injection and is designed to improve postprandial blood glucose control while reducing the risk of late hypoglycemia.
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Meanwhile, Dazparda®, a biosimilar insulin aspart product, is approved for adults, adolescents, and children aged one year and older. The therapy offers rapid onset of action within 10 to 20 minutes and provides effective blood glucose management following meals. Both biosimilars are delivered through prefilled injection pens, enhancing convenience for diabetes patients requiring daily insulin therapy.
Sandoz Expands Leadership in the Global Biosimilars Market
Sandoz executives described the approvals as strategically important for the company’s growing biosimilars business and broader diabetes franchise. Earlier this year, the company also secured European Commission approval for Ondibta® (insulin glargine), further expanding its insulin biosimilar portfolio.
The company emphasized that affordable biosimilar insulin therapies could help healthcare systems manage rising diabetes treatment costs while improving patient access to life-saving medicines. Sandoz entered into a commercialization agreement with Gan & Lee Pharmaceuticals in 2018 covering biosimilar versions of insulin aspart, lispro, and glargine, with Gan & Lee responsible for development, manufacturing, and supply.
Industry analysts view the approvals as another sign of accelerating biosimilar adoption in Europe, particularly within diabetes care where pricing pressures and patient demand continue to grow. Biosimilars are increasingly recognized as critical tools for reducing healthcare costs while maintaining therapeutic effectiveness comparable to originator biologic medicines.
Diabetes Market Growth Fuels Biosimilar Competition
The European Commission approvals also strengthen Sandoz’s position in a global biosimilars market projected to exceed USD 320 billion over the next decade, according to company estimates. Sandoz currently markets a global portfolio of 13 biosimilars and continues expanding its pipeline in oncology, immunology, endocrinology, and chronic disease management.
Healthcare experts believe broader biosimilar insulin adoption may help address treatment affordability challenges faced by millions of diabetes patients while improving long-term disease management outcomes. With diabetes-related complications including heart disease, kidney failure, blindness, stroke, and amputations continuing to rise globally, affordable insulin access remains a major public health priority.
Source: Sandoz press release
