Solumarv

Solumarv was expected to be used to treat patients with diabetes who require insulin to control their blood sugar levels.

Diabetes is a condition in which the body does not produce enough insulin to control the level of blood sugar or in which the body is unable to use insulin effectively. Solumarv was intended as a replacement for the insulin made by the body.

The company presented results of studies in healthy people designed to show that Solumarv is similar to its reference medicine Humulin S in terms of biological activity and how the body handles the medicine. Two additional studies in patients with type 1 and type 2 diabetes compared the safety and effectiveness of Solumarv and Humulin S.

The CHMP’s main concern was that the company did not define the manufacturing process for Solumarv in sufficient detail. As such, it was not possible to show that Solumarv used in clinical studies was representative of batches intended for the market and that its quality was comparable to Humulin S’s.

The CHMP concluded that Solumarv could not be approved as a biosimilar of Humulin S and recommended that it be refused marketing authorisation.

The company informed the CHMP that there are no clinical trials or compassionate use programmes affected by the Committee’s opinion.