In September and October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of EU-wide authorisations for 6 new medicines (Table 1) and 9 new biosimilar medicines (Table 2). The CHMP also recommended the authorisation of 1 new generic medicine and 15 new indications for medicines already authorised in the EU.1,2
Table 1.
EMA approvalsa for new medicines (September–October 2025).
| Disease area | Medicine name (non-proprietary name) | Marketing authorisation holderb | Properties | Indication | Approval month |
|---|---|---|---|---|---|
| Endocrinology | Kyinsu (insulin icodec/semaglutide) | Novo Nordisk | insulin analogue and GLP-1 receptor agonist | Type 2 diabetes mellitus | September 2025 |
| Lynkuet (elinzanetant) | Bayer | non-hormonal, selective, NK-1 and NK-3 receptor antagonist | Vasomotor symptoms associated with menopause or AET related to breast cancer | September 2025 | |
| Haematology/Haemostaseology | Wayrilza (rilzabrutinib) | Sanofi | BTK inhibitor | Immune thrombocytopenia | October 2025 |
| Infections | Enflonsia (clesrovimab) | Merck Sharp & Dohme | Antiviral monoclonal antibody binding to the neonatal Fc receptor | Prevention of lower respiratory tract disease caused by respiratory syncytial virus | September 2025 |
| Neurology | Imaavy (nipocalimab) | Janssen-Cilag | Selective immunosuppressant binding to the neonatal Fc receptor | generalised Myasthenia Gravis | September 2025 |
| Pneumology/Allergology | Brinsupri (brensocatib) | Insmed | Reversible DPP1 inhibitor reducing NSP activity neutrophil serine proteases | Non-cystic fibrosis bronchiectasis | October 2025 |
AET: adjuvant endocrine therapy; BTK: Bruton's tyrosine kinase; DPP1: dipeptidyl peptidase 1; Fc: fragment crystallizable; GLP-1: glucagon-like peptide 1; NK: neurokinin; NSP: neutrophil serine proteases.
The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications. EMA's opinion refers to its scientific recommendation, upon which the European Commission bases its legal decision to grant an EU-wide marketing authorisation.
Upon granting of the marketing authorisation, the marketing authorisation holder is allowed to market the product in all EU/EEA Member States. The medicine might be marketed by a different license holder outside the EU/EEA.
Table 2.
EMA approvalsa for new biosimilar medicines (September–October 2025).
| Disease area | Medicine name (non-proprietary name) | Marketing authorisation holderb | Reference medicine | Properties | Indication | Approval month |
|---|---|---|---|---|---|---|
| Endocrinology | Acvybra (denosumab) | Reddy Holding | Prolia (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Osteoporosis and bone loss | September 2025 |
| Denosumab Intas (denosumab) | Intas Third Party Sales | Prolia (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Osteoporosis and bone loss | September 2025 | |
| Kefdensis (denosumab) | Stada Arzneimittel | Prolia (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Osteoporosis and bone loss | September 2025 | |
| Ponlimsi (denosumab) | Teva | Prolia (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Osteoporosis and bone loss | September 2025 | |
| Degevma (denosumab) | TEVA | Xgeva (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Skeletal related events with advanced malignancies and treatment of giant cell tumour of bone | September 2025 | |
| Xbonzy (denosumab) | Reddy Holding | Xgeva (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Skeletal related events with advanced malignancies and treatment of giant cell tumour of bone | September 2025 | |
| Zvogra (denosumab) | Stada Arzneimittel | Xgeva (denosumab) | Monoclonal IgG2 antibody targeting RANKL | Skeletal related events with advanced malignancies and treatment of giant cell tumour of bone | September 2025 | |
| Immunology/Rheumatology/Transplantation | Gobivaz (golimumab) | Advanz Pharma | Simponi (golimumab) | monoclonal antibody inhibiting TNF-a | Rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis | September 2025 |
| Usgena (ustekinumab) | Stada Arzneimittel | Stelara (ustekinumab) | IgG1κ monoclonal antibody binding to IL-12 and -23 | Plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis | September 2025 |
TNF-a: tumour necrosis factor alpha; IgG: immunoglobulin G; IL: interleukin; RANKL: receptor activator of nuclear factor Kappa-Β ligand.
aThe European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications. EMA's decision refers to its scientific recommendation, upon which the European Commission bases its legal decision to grant an EU marketing authorisation.
Biosimilars are biological medicines highly similar to a reference medicine already on the market. In the EU, these products are considered interchangeable.
Upon granting of the marketing authorisation, the marketing authorisation holder is allowed to market the product in all EU/EEA member states. The medicine might be marketed by a different license holder outside the EU/EEA.
Notably, the CHMP recommended granting an EU-wide marketing authorisation for the medicine Brinsupri (brensocatib), a competitive dipeptidyl peptidase 1 inhibitor indicated for the treatment of patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB) who had 2 or more exacerbations in the prior 12 months.3 The medicine was supported through EMA's PRIority MEdicines (PRIME) scheme.4 There are currently no medicines authorised for the treatment of NCFB; Brinsupri was considered to be of major benefit to public health and was reviewed under an accelerated timetable.5 The CHMP also recommended the authorisation of Enflonsia (clesrovimab), a single-dose antiviral monoclonal antibody for the prevention of lower respiratory tract disease caused by the respiratory syncytial virus (RSV) in neonates and infants that has shown efficacy in these populations in their first RSV season.
For Oxbryta (voxelotor), a medicine previously authorised in the EU for the treatment of adults with sickle cell disease,6 the CHMP confirmed the interim measure to suspend its authorisation as the benefit-risk balance can no longer be considered positive after clinical trial data identified an increased mortality risk in patients taking the medicine.
Other new medicines and new biosimilars recommended for authorisation by the CHMP included products for the treatment of type 2 diabetes mellitus; myasthenia gravis; vasomotor symptoms associated with menopause and endocrine therapy; osteoporosis and bone complications; psoriasis, Crohn's disease and ulcerative colitis; and different forms of arthritis.
The CHMP held its eleventh meeting of the year on November 10–13, 2025 and will next meet on December 8–11, 2025. Agendas for CHMP meetings are available on the EMA website.7
References
- 1.European Medicines Agency Meeting highlights from the committee for medicinal products for human use (CHMP) 15-18 September 2025. 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-september-2025
- 2.European Medicines Agency Meeting highlights from the committee for medicinal products for human use (CHMP) 13-16 October 2025. 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-october-2025
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- 4.European Medicines Agency PRIME: priority medicines. 2025. https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines
- 5.European Medicines Agency Accelerated assessment. 2025. https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment
- 6.European Medicines Agency . 2025. EMA confirms suspension of sickle cell disease medicine Oxbryta. [Google Scholar]
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