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Questions & Answers

On 25 January 2018, 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).

The full indication is: "Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above."

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Semglee (English only) 2018-01-26  

Key facts

Product details for Semglee
INN or common name

insulin glargine

Therapeutic area Diabetes Mellitus, Type 2
Active substance

insulin glargine

Date opinion adopted25/01/2018
Company name

Mylan S.A.S.

Application typeInitial authorisation

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