The Committee for Medicinal Products for Human Use (CHMP) has given its recommendation for the marketing authorization of Insulin aspart Sanofi.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) has recommended that marketing authorization be granted for a biosimilar insulin aspart developed by Sanofi and intended for the treatment of diabetes mellitus.
A final decision from the European Commission is pending.
CHMP said the product would be marketed as a solution for injection (100 units/mL). The active substance is insulin aspart, a fast-acting insulin analogue. In the body, this is absorbed more rapidly than human insulin and can therefore act faster.
The replacement insulin acts similarly to naturally produced insulin. It facilitates uptake of glucose into skeletal muscle and fat tissue and inhibits glucose output from the liver.
The biosimilar’s reference product is NovoRapid, which was authorised in the European Union on September 7, 1999. Data show that Insulin aspart Sanofi, the product’s brand name, has comparable quality, safety, and efficacy to NovoRapid, CHMP said.