CHMP recommends Semglee,insulin glargine biosimilar, for treatment of diabetes.Mylan + Biocon

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Semglee, intended for treatment of diabetes. The applicant for this medicinal product is Mylan S.A.S. Semglee will be available as a solution for injection (100 units/ml). The active substance of Semglee is insulin glargine, a long-acting insulin analogue (ATC code: A10A E04). Insulin glargine binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. Semglee is a biosimilar medicinal product. It is highly similar to the reference product Lantus (insulin glargine), which was authorised in the EU on 9 June 2000. Data show that Semglee has comparable quality, safety and efficacy to Lantus (insulin glargine).