EMA Authorised: Semglee (insulin glargine) — Biosimilar Collaborations Ireland Limited

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Summary

EMA authorized Semglee as a biosimilar insulin glargine for diabetes mellitus. The marketing authorization holder is Biosimilar Collaborations Ireland Limited.

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Diseases / indications

• Diabetes Mellitus

Drugs mentioned

• Semglee (insulin glargine)

Snippet

Status: Authorised. Therapeutic area: Diabetes Mellitus. MAH: Biosimilar Collaborations Ireland Limited. Decision date: 19/02/2026