In Europe, during 2022, 89 new medicines were authorised, of which 48 containing new active substances, 8 biosimilars, 23 equivalents and 10 between hybrid medicines, known active substances and medicines authorised with the informed consent procedure.

Antineoplastics and immunomodulators - intended for the treatment of certain types of solid tumours (such as lung, prostate and liver cancer), blood cancers (such as myeloma, lymphoma and leukaemia) and autoimmune diseases - remain the most represented categories (a total of 37.5%) among medicinal products containing new active substances authorised by the European Medicines Agency (EMA). They are followed, in descending order, by anti-infectives for systemic use, medicines for the gastrointestinal system and metabolism, and medicines for the nervous system.

These are some of the information contained in the 5th edition of the Report "Horizon Scanning: scenario of incoming medicines", published by the Italian Medicines Agency with the aim of providing information on new medicines and new therapies, which have received a positive opinion from the EMA or may have one in the following years. The analysis, in particular, focuses on medicines containing new active substances, biosimilars and equivalents, for a total of 79 new authorised medicines.

During 2022, EMA authorised 20 orphan medicinal products containing new active substances, 5 of which are advanced therapy medicinal products (specifically, gene therapies), and gave positive opinions on 91 new indications of 67 already authorised medicinal products. The largest number of new therapeutic indications concerns antineoplastic and immunomodulatory medicinal products, which with 43 new indications account for 47.3% of the total.    

Ninety-two new medicines are under evaluation by the EMA at the beginning of 2023, with an opinion expected later this year: 61 are medicines containing new active substances (of which 28 are orphan drugs), 17 are equivalents and 14 are biosimilars.    
The most numerous are antineoplastics (25), followed by immunosuppressants (14) and nervous system medicines (6).

Sixty-four new therapeutic indications are also under evaluation (out of a total of 58 medicinal products already authorised), belonging to nine main areas: solid tumours, infectious diseases, autoimmune diseases and allergies, blood cancers, neurological, neurometabolic and sensory diseases, cardiovascular diseases and metabolic syndromes.

Finally, 111 medicines have been admitted to the PRIME programme, aimed at promising medicines of great public health interest, intended for patients with unmet treatment needs, for which early development support is provided. Most of these are advanced therapies and the oncology area is the most represented, followed by the areas of haematology-haemostasiology, endocrinology-gynaecology-metabolism, neurology and vaccines.