In January and February 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of an EU-wide marketing authorisation for seven new medicines (Table 1) and three new biosimilar products (Table 2). The CHMP also recommended two new generic medicines and extensions of the indication for 24 medicinal products already authorised in the EU.1,2
Table 1.
EMA approvals for new medicines (January–February 2025).
| Disease area | Medicine name (non-proprietary name) | Marketing authorisation holdera | Properties | Indication | Approval month |
|---|---|---|---|---|---|
| Dermatology | Vyjuvek (beremagene geperpavec) | Krystal Biotech Netherlands | Gel containing HSV-1-based gene therapy product correcting COL7 gene mutations | Dystrophic epidermolysis bullosa | February 2025 |
| Immunology | Deqsiga (human normal immunoglobulin) | Takeda Manufacturing | Broad-spectrum IgG antibodies against infectious agents | Primary and secondary immunodeficiencies, primary immune thrombocytopenia, Guillain-Barré syndrome, Kawasaki disease, chronic inflammatory demyelinating polyradiculoneuropathy, and multifocal motor neuropathy | February 2025 |
| Infections | Capvaxive (pneumococcal polysaccharide conjugate vaccine (21-valent)) | Merck Sharp & Dohme | Vaccine containing 21 pneumococcal polysaccharide serotypes | Prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae | January 2025 |
| Vimkunya (Chikungunya vaccine (recombinant, adsorbed)) | Bavarian Nordic | Adjuvanted vaccine containing recombinant chikungunya virus-like particles | Prevention of disease caused by chikungunya virus | January 2025 | |
| Oncology | Datroway (datopotamab deruxtecan) | Daiichi Sankyo Europe | Monoclonal antibody-drug conjugate binding to TROP2-expressing tumour cells and releasing deruxtecan | HR+/HER− breast cancer | January 2025 |
| Lynozyfic (linvoseltamab) | Regeneron Ireland | Bispecific monoclonal antibody targeting CD3 and BCMA | Multiple myeloma | February 2025 | |
| Tivdak (tisotumab vedotin) | Pfizer Europe | Monoclonal antibody-drug conjugate binding to TF-expressing tumour cells and releasing MMAE | Cervical cancer | January 2025 |
BCMA: B-cell maturation antigene;
MMAE: Monomethyl auristatin E.
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 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 medicinal product might be marketed by a different license holder outside the EU/EEA.
Table 2.
EMA approvals for new biosimilar medicines (January–February 2025).
| Disease area | Medicine name (non-proprietary name) | Medicine Authorisation holdera | Reference medicine | Properties | Indication | Approval month |
|---|---|---|---|---|---|---|
| Haematology and Haemostaseology | Dyrupeg (pegfilgrastim) | CuraTeQ Biologics | Neulasta (pegfilgrastim) | Human granulocyte-colony stimulating factor | Neutropenia in patients treated with cytotoxic chemotherapy for malignancy | January 2025 |
| Ophthalmology | Pavblu (aflibercept) | Amgen Technology | Eylea (aflibercept) | Recombinant receptor fusion protein blocking VEGF-A and PIGF | Age-related macular degeneration and visual impairment | January 2025 |
| Skojoy (aflibercept) | Amgen Technology | Eylea (aflibercept) | Recombinant receptor fusion protein blocking VEGF-A and PIGF | Age-related macular degeneration and visual impairment | January 2025 |
VEGF-A: Vascular endothelial growth factor A;
PIGF: Phosphatidylinositol-glycan biosynthesis class F protein.
The 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 medicinal product might be marketed by a different license holder outside the EU/EEA.
Of particular note are the positive opinions for Vimkunya (Chikungunya vaccine [recombinant, adsorbed]), the first vaccine to protect adolescents aged 12 years and older against disease caused by the chikungunya virus,3 and Vyjuvek (beremagene geperpavec), the first topical gene therapy treatment for dystrophic epidermolysis bullosa.4 In addition, the CHMP recommended an extension of the marketing authorisations of Kaftrio (ivacaftor/tezacaftor/elexacaftor) and Kalydeco (ivacaftor). Both products are CFTR correctors/potentiators and are authorised for the treatment of cystic fibrosis in patients aged 2 years and older with an F508del mutation in the CFTR gene, and the EMA now recommends that their use be extended to include all patients with at least one non-class I CFTR mutation.5
The CHMP also adopted a positive opinion for Ivermectin/Albendazole (a fixed-dose combination of ivermectin and albendazole) a medicine intended for the treatment of helminth infections, which was evaluated under EU-M4All, a procedure that supports global regulatory capacity building.6 Although this medicine is not intended for use in the EU, non-EU regulators that might have limited capacity for the evaluation of new medicines can rely on CHMP's scientific assessment to decide on their use.
Other new medicines and new biosimilars recommended for authorisation included products for the treatment of immune diseases, streptococcal infection, cancers, neutropenia, and wet age-related macular degeneration. The CHMP held its third meeting of 2025 on March 24–27, and will next meet on April 22–25, 2025.
References
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