On 15 May 2026, Sandoz announced that the European Commission has granted marketing authorisation for Bysumlog®, biosimilar to Eli Lilly’s Humalog® (insulin lispro), and Dazparda®, biosimilar to Novo Nordisk’s NovoRapid® (insulin aspart). Both biosimilars are approved for the treatment of diabetes across all indications of the respective reference products and received a positive CHMP opinion in February 2026.
Bysumlog® and Dazparda® were developed by Beijing-headquartered Gan & Lee Pharmaceuticals. Under a December 2018 commercialisation agreement, Gan & Lee is responsible for development, manufacture and supply of insulins aspart, lispro and glargine, and Sandoz has commercialisation rights to the products in Europe and other key territories, including Japan, South Korea, Canada, Australia and New Zealand.
The only other insulin lispro biosimilar approved in Europe is Sanofi’s “Insulin lispro Sanofi”, which was approved in 2017 (known as Admelog® in the US). Insulin aspart biosimilars approved in Europe are Biocon’s Kirsty® (previously Kixelle®) (approved February 2021) and Insulin aspart Sanofi (approved June 2020).