Lancet Reg Health Eur、2025年4月1日公開の論文。
2025年1月と2月、欧州医薬品庁（EMA）の欧州医薬品評価委員会（CHMP）は、7つの新薬（表 1）と3つのバイオシミラー新薬（表 2）について、EU全域での販売承認を推奨した。 CHMPはまた、2つの新しいジェネリック医薬品と、EUですでに承認されている24の医薬品の適応拡大を推奨した。
ニュースソース
Juan Garcia Burgos Steffen Thirstrup（European Medicines Agency, Amsterdam）：EMA approvals of new medicinal products and new biosimilar products in January and February 2025.
Lancet Reg Health Eur. 2025 Apr 1:51:101279. doi: 10.1016/j.lanepe.2025.101279. eCollection 2025 Apr. DOI: 10.1016/j.lanepe.2025.101279 （フリーアクセス）
Table 1EMA 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.
a 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 2EMA 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.
a 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.