EMA approves first-ever insulin biosimilar, Lilly/BI's Abrasia
- In June, the Committee for Medicinal Products for Human Use determined that Abrasia has comparable quality, safety, and efficacy profiles to Sanofi’s Lantus.
- Abrasia is a basal insulin used to treat hyperglycemia in patients with type 1 and type 2 diabetes. It is being marketed jointly by Eli Lilly and Boehringer Ingelheim (BI).
- Abrasia was tentatively approved by the FDA last month.
Abrasia’s approval covers treatment of diabetes in adults, adolescents, and children starting from age two. Not only does Abrasia provide patients with a less expensive basal insulin option -- patients also have access to substantial support from the Lilly-BI Alliance, which has already generated three other diabetes products in Europe.
The approval also sets up an immediate confrontation with Sanofi, whose flagship insulin product Lantus brings in about $8 billion per year in sales. Get ready to see a lot more of these biosimilar showdowns: Many of the top-selling drugs in 2013 were biologics, making them ripe targets for companies conducting biosimilar development. Biosimilars may make up as much as 10% of the biopharma market by 2020.
- pharmafile.com Lilly and Boehringer diabetes biosimilar sees EU approval