In Europe, during 2023, 78 new medicines received a positive opinion from the EMA CHMP, of which 43 containing new active substances, 8 biosimilar medicines, 14 equivalents and 13 hybrid medicines, authorised through the informed consent procedure and known active substances.

Antineoplastic drugs and immunomodulators - intended for the treatment of certain types of solid tumours (such as breast, lung, oesophageal cancer and cholangiocarcinoma), blood tumours (such as myeloma, lymphoma and leukaemia) and autoimmune diseases - remain the most represented categories (a total of 49.2%) among medicines containing new active substances authorised by the European Medicines Agency (EMA). They are followed, in descending order, by medicines for the nervous system, anti-infectives for systemic use, including vaccines, and medicines for diseases of the blood and haematopoietic organs.

This is some of the information contained in the 6th edition of the “Horizon Scanning: scenario of upcoming medicines” report, published by the Italian Medicines Agency. The Report aims to provide information on new medicines and new extensions of therapeutic indications that have received a positive opinion from the EMA or may receive one in the coming years.

Only medicines consisting of new active substances, biosimilars and equivalents were included in the Report, for a total of 63 new medicines, considering the exclusion of two medicines withdrawn by the owner after the positive opinion of the CHMP.

During 2023, EMA authorised 20 orphan medicinal products containing new active substances, one of which for advanced therapies (specifically, gene therapy).

Furthermore, 78 new indications of 69 already authorised medicines have received a positive opinion from the EMA. The largest number of new therapeutic indications concerns antineoplastic and immunomodulatory drugs, which with 34 new indications represent 43.6% of the total.

One hundred and four new medicines are under evaluation by the EMA at the beginning of 2024, with an opinion expected later this year: 65 are medicines containing new active substances (of which 24 are orphan drugs), 17 are equivalents and 22 are biosimilars.

The most numerous are medicines in the therapeutic area of oncology and oncohaematology (28), followed by medicines for haematological diseases (13) and medicines for the nervous system (10).

There are also 73 new therapeutic indications under evaluation (related to 69 already authorised medicinal products), belonging to the following main areas: oncology/oncohaematology, immunology-rheumatology-transplantation, infectious diseases, neurology/psychiatry, haematology, pneumology-allergology, cardiovascular, dermatology.

Finally, 129 medicinal products were initially admitted to the PRIME programme, which is aimed at promising drugs of high public health interest, intended for patients with unmet treatment needs, for which scientific and regulatory support is provided during the development phase. These are, for the most part, advanced therapies of which the oncology area is the most represented, followed by the areas of haematology, endocrinology-gynaecology-fertility-metabolism, neurology and vaccines.

Published on: 13 May 2024