During 2024, the EMA recommended 114 medicines for marketing authorisation, including 46 with new active substances that had never been authorised in the European Union (EU). Among these, several treatments stood out for their significant public health impact or innovation nature. These included the first medicine for early-stage Alzheimer’s disease, a needle-free and more compact form of adrenaline for allergic reactions, a novel therapy for tumours associated with von Hippel-Lindau disease, and two new antibiotics for severe infections. 

In comparison, the EMA recommended 77 medicines for marketing authorisation in 2023, including 39 with novel active ingredients that were previously unapproved in the EU. Many of these medications addressed critical public health concerns or represented notable advancements in medical innovation [1]. 

In 2024, oncology remained the dominant therapeutic area, with 28 recommendations for new cancer treatments.

Additionally, the EMA issued 28 recommendations for new biosimilars, targeting a wide range of conditions, including cancer, osteoporosis, macular degeneration, and immune-related diseases like plaque psoriasis, ulcerative colitis, and Crohn’s disease, see Table 1. These biosimilars are expected to enhance patient access to essential treatments, making life-changing medicines more affordable and widely available.

A significant milestone in neurology was achieved with the approval of Leqembi (lecanemab), the only new biological medicine authorized in 2024. Leqembi is indicated for the treatment of mild cognitive impairment (including memory and thinking difficulties) or mild dementia associated with early-stage Alzheimer’s disease. It is specifically approved for patients who carry one or no copies of the ApoE4 gene, which codes for the apolipoprotein E protein.

By the end of December 2024, a total of 17 biosimilars have been withdrawn after approval. Additionally, four biosimilars were withdrawn before gaining approval, and two were refused approval. These biosimilars fall into the following therapeutic classes: 1) human growth hormone; 2) granulocyte colony-stimulating factor; 3) erythropoiesis stimulating agent; 4) insulin; 5) parathyroid hormone; and 6) monoclonal antibody [2].

Related article
ASCO policy statement on biosimilars and interchangeables in oncology updated

References
1. GaBI Online - Generics and Biosimilars Initiative. Highlights of EMA biosimilar approvals in 2024 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/reports/highlights-of-ema-approvals-in-2023-focus-on-cancer-medicines
2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Mar 28]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe

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