Sandoz Group AG confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals. Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults and children1, while Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents and children aged one year or more .
Both biosimilar insulins have equivalent efficacy and comparable safety to their respective reference medicines, Humalog® and NovoRapid® . Following these approvals, Bysumlog and Dazparda have the potential to increase competition, improve affordability and expand access to insulin treatment options for millions of people living with diabetes across Europe. Diabetes is a chronic condition that occurs when either the pancreas does not produce enough insulin, a hormone that regulates blood glucose, or when the body cannot effectively use the insulin it produces.
The disease and its complications can cause blindness, kidney failure, heart attacks, stroke and lower-limb amputation in some patients . An estimated 66 million adults aged 20?79 in Europe live with diabetes and this is projected to rise by 10% to 72 million by 2050, with related healthcare expenditure approaching USD 200 billion . Sandoz entered into an agreement with Gan & Lee in December 2018 to commercialise biosimilar versions of the insulins aspart, lispro and glargine.
Under the terms of the agreement, Sandoz will commercialise in Europe and other key territories around the world, while Gan & Lee is responsible for development, manufacturing and supply. The approvals contribute to the continued Sandoz leadership and pioneering legacy in biosimilars, dating back to the introduction of the first biosimilar in 2006. They underscore the company?s commitment to help millions of patients access biologic medicines sustainably and affordably through a global portfolio of 13 biosimilars, supported by an industry-leading pipeline.
They further strengthen the Sandoz position in diabetes, while representing another step towards the overall strategic objective of capitalising on a projected approximately USD 320 billion biosimilar market opportunity over the next 10 years .
