Nine of the 14 medicines the CHMP backed in September were biosimilars
Seven of those nine were denosumab. The committee's September opinions also covered an RSV antibody for infants, a first EU treatment for IgG4-related disease, and four withdrawn applications.
The European Medicines Agency's human medicines committee recommended 14 medicines for approval at its 15–18 September meeting, alongside six extensions of therapeutic indication [s1]. The composition of those 14 is the more interesting number: four were new non-orphan medicines, nine were biosimilars, one was a generic or hybrid, and none were orphan medicines [s1].
Seven of the nine biosimilars were denosumab [s1].
The denosumab cluster
Acvybra, Denosumab Intas, Kefdensis and Ponlimsi received positive opinions for osteoporosis and bone loss; Degevma, Xbonzy and Zvogra for prevention of skeletal-related events in adults and for treatment of adults and skeletally mature adolescents with giant cell tumour of bone [s1]. The remaining two biosimilars were Gobivaz (golimumab) and Usgena (ustekinumab) [s1].
Seven biosimilars of a single reference product clearing a single committee meeting is a pattern that says more about patent expiry timing than about the underlying science. Denosumab's originator exclusivity in Europe has lapsed, and the queue that had built behind it is now discharging. For health systems, the practical consequence is competition on price for a widely used osteoporosis therapy; for the committee, it is a large volume of comparability assessments producing a small amount of new clinical information.
The four new medicines
Enflonsia (clesrovimab) received a positive opinion for prevention of respiratory syncytial virus lower respiratory tract disease in neonates and infants [s1]. EMA's summary notes that almost all children get an RSV infection by the age of two, and that while most recover quickly, RSV can cause severe illness leading to hospitalisation and death [s1].
The trial evidence appeared in the New England Journal of Medicine the day before the opinion was adopted. Healthy preterm and full-term infants entering their first RSV season were randomised 2:1 to a single intramuscular 105-mg dose of clesrovimab or placebo [s2]. Among 3,614 infants who received an injection, RSV-associated medically attended lower respiratory infection through 150 days occurred in 60 of 2,398 in the clesrovimab group (2.6%) and 74 of 1,201 on placebo (6.5%), an efficacy of 60.4% (95% CI, 44.1 to 71.9; P<0.001) [s2]. RSV-associated hospitalisation occurred in 9 of 2,398 versus 28 of 1,201, an efficacy of 84.2% (95% CI, 66.6 to 92.6; P<0.001) [s2]. Serious adverse events were reported in 11.5% of the clesrovimab group and 12.4% of the placebo group [s2].
The gap between the two efficacy figures is worth holding on to: the antibody prevents roughly three in five medically attended lower respiratory infections but roughly five in six hospitalisations, which is the pattern expected of a product that blunts severity rather than blocking infection outright.
Imaavy (nipocalimab) received a positive opinion as add-on to standard therapy for generalised myasthenia gravis [s1]. Kyinsu (insulin icodec / semaglutide) was backed for adults with type 2 diabetes insufficiently controlled on basal insulin or GLP-1 receptor agonists, used alongside diet, exercise and oral medicines [s1]. Lynkuet (elinzanetant) received a positive opinion for moderate-to-severe vasomotor symptoms associated with menopause [s1]. A generic, Rivaroxaban Koanaa, was also backed [s1].
A first for IgG4-related disease
The committee recommended extending Uplizna (inebilizumab), currently used in neuromyelitis optica spectrum disorders, to include active immunoglobulin G4-related disease — a rare autoimmune condition for which, EMA notes, there are currently no authorised medicines in the EU [s1]. Five further indication extensions were recommended, for Bimervax, Dupixent, Keytruda, Koselugo and Tezspire, with a new pharmaceutical form and strength for subcutaneous Keytruda [s1].
What did not get through
Four initial marketing authorisation applications were withdrawn: Amtagvi (lifileucel) for unresectable or metastatic melanoma; Fanskya (mozafancogene autotemcel) for paediatric Fanconi anaemia type A; and Tuzodi and Omforro, both midazolam products [s1]. Withdrawal is a company decision rather than a refusal, and usually signals that the applicant judged the committee's questions unanswerable on the current dossier.
After re-examination at the applicant's request, the CHMP confirmed its refusal of Atropine sulfate FGK for myopia in children aged 6 to 10 [s1]. A separate re-examination went the other way: Winlevi (clascoterone) for topical treatment of acne vulgaris in adults and adolescents was recommended for approval, with the positive opinion adopted in August 2025 [s1].
The committee also gave a positive opinion to update the Bimervax COVID-19 vaccine composition to target the SARS-CoV-2 LP.8.1 variant, in line with the recommendation from EMA's Emergency Task Force for the 2025/2026 vaccination campaign [s1]. It adopted a new route of administration for Lunsumio, and changes to the indication and contraindications of Norvir (ritonavir) [s1].
One extension was declined but partly accommodated: the committee did not recommend extending Lutathera to adolescents aged 12 and over with unresectable or metastatic, somatostatin receptor-positive gastro-entero-pancreatic neuroendocrine tumours, but agreed that relevant study data be added to the product information so clinicians have access to it [s1].
The running totals
Through September, EMA counted 85 positive opinions on new medicines in 2025, against five negative opinions and 17 withdrawn applications; 65 positive opinions on extensions of indication had been adopted [s1]. September itself contributed no negative opinions [s1].
A positive CHMP opinion is not an authorisation. Each is followed by a European Commission decision before the medicine can be marketed, and the pending-decision status is noted against each product in EMA's listing [s1].
This article is informational and is not medical advice.
Sources
- [s1] European Medicines Agency, "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025," published 19 September 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-15-18-september-2025
- [s2] "Clesrovimab for Prevention of RSV Disease in Healthy Infants," New England Journal of Medicine, published online 17 September 2025. https://doi.org/10.1056/NEJMoa2502984
Sources
- Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025 — European Medicines Agency , September 19, 2025
- Clesrovimab for Prevention of RSV Disease in Healthy Infants — New England Journal of Medicine , September 17, 2025
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