The European Medicines Agency (EMA) has published a draft product-specific bioequivalence guidance for semaglutide, the active ingredient in Novo Nordisk's blockbuster diabetes and weight-loss drugs Ozempic and Wegovy. The guidance, adopted by the Committee for Medicinal Products for Human Use (CHMP) on 11 May 2026 and released for public consultation on 14 July 2026, covers multiple strengths of semaglutide solution for injection in pre-filled pens, including the FlexTouch device. The consultation runs until 31 October 2026.
The document, drafted by the Methodology Working Party (MWP) on 29 April 2026, outlines the requirements for generic manufacturers seeking to demonstrate bioequivalence to the reference product. Key requirements include a single-dose, cross-over study design in healthy volunteers, with the option of fasting or fed conditions. Prior to conducting a bioequivalence study, manufacturers must demonstrate sameness of the semaglutide substance. The guidance applies to strengths of 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg, depending on the formulation.
The guidance is not legally binding but provides a scientific framework for companies developing generic versions of semaglutide, which has been under patent protection. Semaglutide, a GLP-1 receptor agonist, generated over €20 billion in sales for Novo Nordisk in 2025, making it one of the world's top-selling drugs. The EMA's move could pave the way for cheaper generic alternatives, potentially reducing healthcare costs for EU health systems and patients. However, the requirement for substance sameness may pose a barrier for some manufacturers, as semaglutide is a complex peptide.
Stakeholders, including generic pharmaceutical companies, patient groups, and healthcare providers, are invited to submit comments via an EUSurvey form by 31 October 2026. The final guidance will be adopted after the consultation period and will influence future marketing authorisation applications for generic semaglutide products in the EU. The EMA's initiative aligns with broader EU efforts to increase access to affordable medicines by facilitating generic competition.