EU CHMP recommends marketing authorisation for the Lusduna (insulin glargine biosimilar) for diabetes- Merck Inc.

The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lusduna (insulin glargine biosimilar), from Merck Inc. intended for treatment of diabetes. Lusduna will be available as a solution for injection (100 units/ml). The active substance of Lusduna is insulin glargine, a long-acting insulin analogue. Insulin glargine binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.

The expected benefit with Lusduna is its ability to lower high blood glucose. The most common side effects are hypoglycaemia, skin and allergic reactions and skin changes at the injection site. Lusduna is a biosimilar medicinal product highly similar to the reference product Lantus. Studies have shown Lusduna to have comparable quality, safety and efficacy to the reference product Lantus. The indication is: treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.