European regulators have issued a green light for the use of Eli Lilly/Boehringer Ingelheim’s basal insulin Abasria, which has the same amino acid sequence as Sanofi’s blockbuster Lantus.
Winning approval for the treatment of diabetes in adults, adolescents and children from the age of two, Abasria has become the first insulin treatment cleared through the European Medicines Agency's biosimilar pathway, offering patients with diabetes a new option for long-lasting sugar control.
The move follows a positive recommendation from the Committee for Medicinal Products for Human Use back in June, which said clinical studies have shown the product to have a comparable quality, safety and efficacy profile to Lantus.
"Basal insulin is an important mainstay of treatment for people with type I and type II diabetes,” said BI’s chief medical officer Klaus Dugi, noting that Abasria will provide healthcare professionals and patients with another option to meet their insulin treatment needs, along with significant expertise and support from the Lilly-Boehringer Ingelheim Alliance.
EU clearance comes hot on the heels of a ‘tentative’ US approval last month, as Lilly/BI’s offering remains the subject of a patent infringement suit filed by Sanofi and therefore to an automatic stay of up to 30 months.