EMA new medicines 2026: 81 EU authorisations in twelve months

EMA new medicines 2026: 81 authorisations in twelve months

This report counts the new marketing authorisations recorded in the European Medicines Agency's public medicines data, as held in our EMA approvals register on 2 October 2026. Between 17 October 2025 and 21 September 2026 the register lists 81 authorisations: 16 in the last quarter of 2025 and 65 in the first nine months of 2026. Each one is a decision by the European Commission, following a positive opinion from the EMA's Committee for Medicinal Products for Human Use, that lets a medicine be sold in every EU member state, including Ireland.

The count includes biosimilars and generics authorised through the centralised procedure as well as new active substances. It does not include nationally authorised medicines, which go through the Health Products Regulatory Authority in Ireland rather than the EMA, nor extensions of existing licences to new indications.

Month by month

Authorisations arrive in waves that follow the committee's meeting calendar and the Commission's decision timetable, which usually runs about two months behind the opinion. November 2025 was the busiest month with 14, followed by April 2026 with 12 and January 2026 with 11. The quietest months were October and December 2025 with one each, and August 2026 with four, the summer lull.

Biosimilars: the denosumab wave

Biosimilars are the largest special category, with 22 of the 81 authorisations, more than a quarter. That continues the pattern of recent years as patents on major biologics expire and competing versions reach the market. One molecule dominates: eight of the 22 biosimilars are versions of denosumab, the antibody used for osteoporosis and for bone complications of cancer, which is why medicines for bone diseases rank third among all therapeutic groups this year. Names authorised include Osqay, Degevma, Xbonzy, Kefdensis and Acvybra.

Ranibizumab, the eye injection for wet macular degeneration, accounts for three biosimilars and golimumab for two. The rest are single entries, including biosimilar versions of insulin lispro, insulin aspart, tocilizumab, teriparatide and etanercept. The two insulin biosimilars are worth noting against the EU shortage list, where branded insulins are among the longest-running ongoing shortages. Five further authorisations are generics approved centrally, such as tafamidis, ruxolitinib, palbociclib and teduglutide versions from Accord and Viatris.

Orphan, PRIME, conditional and advanced therapies

Fifteen authorisations are orphan medicines, designated for rare diseases affecting fewer than five in 10,000 people in the EU. They include Nezglyal, Daybu, Vijoice, Redemplo, Imdylltra, Zepzelca, Joenja, Xolremdi, Palsonify, Ojemda, Kygevvi, Rezurock, Aqneursa, Waskyra and Wayrilz. Orphan status brings ten years of market exclusivity in the EU, so these fifteen set the shape of rare-disease treatment for the decade ahead.

Six medicines received a conditional marketing authorisation, granted on less complete data where the medicine addresses an unmet need and the company commits to further studies: Vijoice, Adstiladrin, Ojemda, Kayshild, Rezurock and Anktiva. Three came through the EMA's PRIME scheme for priority medicines, which gives early scientific support to promising treatments: Kygevvi, Teizeild and Brinsupri. Two are advanced therapy medicinal products, the category that covers gene and cell therapies: Adstiladrin, a gene therapy for bladder cancer, and Waskyra, developed by the Italian charity Fondazione Telethon, one of the rare cases of a non-profit holding an EU marketing authorisation.

Which therapeutic groups lead

Grouping by the EMA's therapeutic classification, antineoplastic agents, the cancer medicines, lead with 10 authorisations, among them the alpelisib medicine Vijoice, the lung cancer antibody Imdylltra, Zepzelca and generic versions of ruxolitinib and palbociclib. Immunosuppressants, which include many of the biosimilar antibodies used in arthritis, psoriasis and inflammatory bowel disease, follow with 9, including Icotyde, Jascayd, Rhapsido and biosimilar tocilizumab and golimumab. Medicines for bone diseases account for 8, lifted by the denosumab biosimilars, and medicines used in diabetes for 7, including liraglutide, insulin lispro, insulin aspart and insulin glargine products and Kayshild, a semaglutide medicine.

Vaccines contribute 5, including two influenza vaccines, an mRNA influenza vaccine, an updated COVID-19 mRNA vaccine and a pertussis vaccine. Other nervous system medicines add 4.

Who holds the authorisations

Sanofi Winthrop Industrie and Stada Arzneimittel hold 4 authorisations each, with Stada holding 2 more under a differently spelled entity. Viatris, Novartis Europharm and Teva hold 3 each, and Lupin Europe and Intas 2 each. The presence of Stada, Viatris, Teva, Lupin and Intas near the top is the biosimilar and generic wave made visible: these are the companies bringing competing versions of off-patent biologics to the EU market.

Irish marketing-authorisation holders

Six of the 81 authorisations are held by companies registered in Ireland. Arrowhead Pharmaceuticals Ireland holds Redemplo, the plozasiran medicine for a rare lipid disorder, which is also an orphan medicine. Biosimilar Collaborations Ireland holds Fubelv, a biosimilar etanercept. ImmunityBio Ireland Limited holds Anktiva, the bladder cancer immunotherapy, under a conditional authorisation. Cytokinetics (Ireland) Limited holds Myqorzo, the aficamten medicine for hypertrophic cardiomyopathy. IntraBio Ireland Limited holds Aqneursa, an orphan medicine for Niemann-Pick disease type C. Theramex Ireland Limited holds Osqay, a denosumab biosimilar.

The holder is the legal entity responsible for the medicine in the EU, and since the UK left the Union many companies have moved that role to an Irish subsidiary. A holder in Ireland does not mean the medicine is made in Ireland; our pharma map shows where manufacturing takes place.

What comes next: 20 positive opinions awaiting a decision

At the same date the register held 20 medicines with a positive committee opinion but no Commission decision yet. Eleven of those opinions were adopted in September 2026, including Adcomfo, Frehemgo, Inijaq, Lifyorli, Povofortay, Sepalna, Zeydovio, Gevalka, Klygefa, VaxRabeo and a ruxolitinib generic from Zentiva. Six were adopted in July 2026, among them Cavoley, Evlarco, Lynavoy, Lyrokaul, Ubeslo and a riociguat generic, and two in June 2026, Nylaspeg and Onswik, the once-weekly insulin. One, Skojoy, has carried a positive opinion since January 2025. Most of these should receive their authorisation before the end of 2026, which would take the twelve-month total past 100. Each pending medicine is listed on the register with its committee opinion date.

Method and sources

We read the EMA's public medicines dataset, which lists every centrally authorised human medicine with its authorisation date, marketing-authorisation holder, therapeutic group and the flags for generic, biosimilar, orphan, PRIME, conditional and advanced therapy status. We counted authorisations dated from 17 October 2025 to 21 September 2026 inclusive, as the register held them on 2 October 2026 at 04:43 UTC. Biosimilar molecules were grouped by international non-proprietary name. Irish holders were identified by the word Ireland in the holder name as the EMA records it. Pending medicines are those with a positive opinion and no authorisation date. Medicine names are given as the EMA records them; descriptions of what each treats come from the EMA's public product information.

Reuse and citation: this analysis is published by Priya Life Science under CC BY 4.0. The source records belong to the European Medicines Agency and are reused under the EMA legal notice. Cite the report using the box below; our methodology page explains the register and corrections are logged on our corrections page.