European Regulatory Approval for Eli Lilly / Boehringer’s Abasria
The European Commission has granted regulatory approval to Eli Lilly and Boehringer Ingelheim’s Abasria for treating diabetes in adults, adolescents and children aged two years and above.
The approval follows EMA’s Committee for Medicinal Products for Human Use (CHMP) positive recommendation earlier this year.
The previous recommendation noted that clinical studies of the insulin showed that Abasria had a comparable quality, safety and efficacy profile to Sanofi’s Lantus.
The basal insulin, which has the same amino acid sequence as Sanofi’s blockbuster Lantus, has become the first insulin treatment cleared through the European Medicines Agency’s (EMA) biosimilar pathway, offering diabetes patients a new option for long-lasting sugar control.
Abasria is intended to provide long-lasting blood sugar control between meals and at night, and will be available in a pre-filled pen and cartridges for a reusable pen.
The European regulatory approval comes shortly after Abasria received ‘tentative’ US FDA approval last month.
Boehringer Ingelheim’s chief medical officer, Klaus Dugi, noted that “basal insulin is an important mainstay of treatment for people with type I and type II diabetes,” adding that “Lilly/Boehringer Ingelheim’s insulin glargine product will provide healthcare professionals and patients with another option to meet their insulin treatment needs.”