EMA CHMP Recommends Seven New Medicines Including Two Insulin Aspart Biosimilars in November 2026

Dual biosimilar positive opinions for insulin aspart signal a tightening EU competitive landscape that manufacturing sites and QA teams should map against their own authorisation timelines now. At its 9–12 November 2026 meeting, the CHMP recommended seven new medicines for marketing authorisation, including biosimilars Garzulys and Donrafylix (both insulin aspart) for diabetes mellitus in adults, adolescents, and children aged one year and above, alongside generic ruxolitinib from Krka for myelofibrosis, polycythaemia vera, and graft-versus-host disease.

For regulatory affairs leads tracking EU market entry, the insulin aspart wave is notable: two biosimilar sponsors cleared the same reference product in the same session, compressing the window before price erosion begins. Manufacturing sites supporting either product will need confirmed GMP compliance across all proposed sites of manufacture before the European Commission converts these opinions into formal decisions, typically within 67 days of a positive CHMP opinion.

Beyond biosimilars and generics, the committee recommended five additional new active substances: aumolertinib (Aumseqa) for non-small cell lung cancer, baxdrostat (Baxfendy) for insufficiently controlled hypertension, sintilimab (Zybrivo) for non-squamous non-small cell lung cancer, and fondaparinux sodium Evumed as a generic anticoagulant. Each recommendation initiates the Commission decision clock and corresponding post-authorisation obligations, including any risk management plan commitments that QA and pharmacovigilance functions must operationalise before launch.

The committee also adopted 11 extensions of therapeutic indication, with obinutuzumab (Gazyvaro) gaining a recommendation for moderate-to-severe active systemic lupus erythematosus and osilodrostat (Isturisa) expanding to adolescents and children aged six and older with endogenous Cushing's syndrome. Extensions carry their own variation dossier requirements and may trigger labelling, storage, or distribution changes that supply-chain and QA teams need to absorb in parallel with any ongoing process validation work.

On the negative side, the CHMP confirmed refusals following re-examination for KemSu (sufentanil/ketamine) in paediatric acute pain and Meplyffa (arimoclomol citrate) in Niemann-Pick disease type C. Applications for Amlypave (anselamimab) and one additional product were withdrawn before opinion. These outcomes close active dossiers but do not preclude re-submission under revised data packages.

The Commission decision converting the insulin aspart biosimilar opinions into enforceable authorisations will set the definitive clock for commercial readiness across manufacturing, QA release, and distribution networks.

Source: European Medicines Agency (EMA) via ema.europa.eu, 13 November 2026.