Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths - Scientific guideline

The draft guidance covers the following products:

• Semaglutide, 0.25, 0.5, 1 and 2 mg solution for injection in pre-filled pen, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen
• FlexTouch, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen

Keywords: Bioequivalence, generics, semaglutide

Open consultation

Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

Draft: consultation open Consultation dates: 14/07/2026 to 31/10/2026 Reference Number: EMA/106257/2026 Summary:

The guidance covers the following products:

• Semaglutide, 0.25, 0.5, 1 and 2 mg solution for injection in pre-filled pen, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen
• FlexTouch, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen

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