EMA recommended 38 new drugs in 2025, fewer than prior year

The European Medicines Agency (EMA) said it recommended approval of more than a hundred new drugs in 2025, of which about 40% were for new active substances that had not previously been authorized in Europe. The agency notes it’s the second-highest number of drug recommendations it has given in the past 15 years.

On 15 January, EMA published its annual report on newly recommended medicines in the economic zone. The agency noted that over the past year it had recommended approval of 104 drugs, of which 38 were new active substances.

Steffen Thirstrup, EMA's chief medical officer, said during a press conference that 2025 had the second-highest number of drug recommendations from the agency's Committee for Medicinal Products for Human Use (CHMP) in the past 15 years.

"Endocrinology was numerically the strongest therapeutic area with 29 recommendations for new medicines," he said. "The majority of those medicines were biosimilars and three of them were new active substances."

Thirstrup said that EMA recommended 18 new oncology drugs last year, which was a bit lower than the previous year. More interestingly, he noted that the largest number of new active substances recommended by EMA was for oncology products, with 14 new oncology drugs containing them.

During the press conference, Thirstrup highlighted several products that were recommended last year, including ImmunityBio's cancer immunotherapy Anktiva (nogapendekin alfa inbakicept). The drug is intended to treat adults with non-muscle invasive bladder cancer (NMIBC). He noted that bladder cancer was one of the most common forms of cancer in the European Union and affects 200,000 people annually, a majority of whom are NIMC.

Furthermore, Thirstrup highlighted the EMA's recommendation of Cordex Biologics' Zemcelpro (dorocubicel/unexpanded umbilical cord cells), a stem cell therapy intended to treat patients with blood cancers who need bone marrow transplants but are unable to find compatible donors. He also highlighted Insmed's Brinsupri (brensocatib).

"This is the first medicine for bronchiectasis in patients who do not have cystic fibrosis," he said. "Bronchiectasis is a serious, chronic lung disease affecting between 400,000 and 3 million people in the European Union."

Thirstrup noted that Brinsupri was also one of three drugs that EMA recommended through its accelerated review program in 2025. The other two drugs were Gilead's Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection and Bavarian Nordic's Vimkunya (chikungunya vaccine (recombinant, adsorbed)) to protect people 12 years and older from the Chikungunya virus.

Biosimilars raise no issues

Other notable findings in EMA's report include recommendations for 12 rare disease drugs and three positive opinions for drugs that will also be used outside the EU as part of its collaboration with the World Health Organization (WHO) under its EU-Medicines for All (EU-M4all) procedure. The agency also recommended authorization of 41 biosimilars.

"This is the highest number of biosimilars we have ever approved in a single year," said Tirstrup. "Twenty-three of these biosimilars contain denosumab, this is a monoclonal antibody to treat osteoporosis, bone loss and prevent bone fractures in patients suffering from these conditions.

"EMA now has 20 years of experience with biosimilars," he added. "Having assessed 180 of these products and approved 160, we have no signs of important safety signals or lack of efficacy compared these products' reference or originator product."

Thistrup also highlighted that based on their success, EMA published a paper in April 2025 on a tailored clinical approach to biosimilar development that aligns with the thinking of other regulators, including the US Food and Drug Administration (FDA), Health Canada, and UK's Medicines and Healthcare products Regulatory Agency (MHRA). He said the approach could reduce the amount of clinical data required by regulators to recommend new biosimilars.

"It is, however, important to stress that we are not intending to lower the scientific or regulatory standards for approval of biosimilars," said Thirstrup. "The possibility of reducing the clinical data and the clinical data needed is fully counter-balanced by the advancements made over the past two decades in our ability to characterize and compare the structure of biological molecules."

"The interest in developing biosimilars seems to continue as we have received last year a high number of requests for scientific advice for biosimilar developments," he added.

Thistrup noted that EMA has received 84 letters of intent from companies to submit marketing authorization applications for the first half of 2026, including 58 with new active substances, 28 orphan drugs, four advanced therapies, three drugs under EU's priority medicines (PRIME) designation, and 19 products from small- and medium-sized enterprises (SME). He noted however that historically products in such letters of intent are not submitted on time.

Heart disease a growing concern

Francesca Day, head of EMA's therapeutics department, also spoke during the press conference and highlighted that data shows that cardiovascular disease is a growing problem in Europe. With that in mind she highlighted several drugs to address the problem, including EMA's positive recommendation for Sanofi's Teizeild (teplizumab), a first-in-class treatment to delay the onset of stage 3 type 1 diabetes in adults and for patients eight years and older with stage 2 type 1 diabetes.

“GLP-1 receptor agnostics remain central in diabetes and weight management for care but also for prevention,” said Day. “The use of Munjaro was extended to include the treatment of adolescents and children from 10 years of age with insufficiently controlled type 2 diabetes.”

She also noted that EMA is evaluating an oral formulation of the GLP-1 receptor agonist Wegovy, which could further increase its adoption.

"We have also received applications for generic liraglutide for both diabetes and weight management. In 2026 we expect continued innovation in weight management and diabetes,” said Day.

EMA also noted that in the past year, it issued negative opinions on 7 drug applications. They include drugs such as Anavex's blarcamesine to treat Alzheimer’s disease and Sarepta Therapeutics' Elevidys (delandistrogene moxeparvovec) for Duchenne muscular dystrophy. The agency also noted that 22 applications were withdrawn by the applicants.

EMA report, EMA press conference

EMA recommended 38 new drugs in 2025, fewer than prior year

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