Dive Brief:
- 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.
Dive Insight:
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.