CHMP recommends Insulin aspart Sanofi, a biosimilar product, intended for the treatment of diabetes mellitus.- Sanofi

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Insulin aspart Sanofi, intended for the treatment of diabetes mellitus. The applicant for this medicinal product is sanofi-aventis groupe. Insulin aspart Sanofi will be available as a solution for injection (100 units/ml). The active substance of Insulin aspart Sanofi is insulin aspart, a fast-acting insulin analogue (ATC code: A10AB04) which is absorbed more rapidly by the body and can therefore act faster than human insulin. The replacement insulin acts in the same way as naturally produced insulin; it works by facilitating uptake of glucose into skeletal muscle and fat tissue, and by inhibiting glucose output from the liver. Insulin aspart Sanofi is a biosimilar medicinal product. It is highly similar to the reference product NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999. Data show that Insulin aspart Sanofi has comparable quality, safety and efficacy to NovoRapid (insulin aspart).