Ninety-two new drugs under Ema evaluation for 2023, especially anticancer

In Europe, 89 new medicinal products are authorized in 2022, of which 48 contain new active substances, 8 biosimilars, 23 equivalents. Green light also for 10 hybrid medicines, known active substances and medicines authorized with the informed consent procedure. The 5th edition of Relationship “Horizon Scanning: scenario of incoming medicines”, published by the Italian Medicines Agency.

04 APR –

In Europe, during 2022, 89 new medicines were authorized, of which 48 containing new active substances, 8 biosimilars, 23 equivalents and 10 between hybrid medicines, known active substances and medicines authorized with the informed consent procedure. On the other hand, ninety-two new medicines are being evaluated by the EMA at the beginning of 2023, with an opinion expected during the year: 61 are medicines containing new active substances (of which 28 are orphan medicines), 17 are equivalent and 14 are biosimilars . The most numerous are antineoplastics (25), followed by immunosuppressants (14) and nervous system drugs (6). 64 new therapeutic indications are also being evaluated (for a total of 58 medicinal products already authorized), belonging to 9 main areas: solid tumours, infectious diseases, autoimmune diseases and allergies, blood cancers, neurological, neurometabolic and sensory diseases, cardiovascular diseases and syndromes metabolic. This is what emerges from the 5th edition of the Report “Horizon Scanning: scenario of incoming medicines”, published by the Italian Medicines Agency (Aifa) with the aim of providing information on new medicines and new therapies, which received a positive opinion of the EMA or which may have it in subsequent years. The analysis, in particular, focuses on medicinal products containing new active substances, biosimilars and equivalents, for a total of 79 new medicinal products authorized.

Antineoplastic and immunomodulators – intended for the treatment of some types of solid tumors (such as lung, prostate and liver cancer), blood tumors (such as myeloma, lymphoma and leukemia) and autoimmune diseases – are confirmed as the most represented categories ( overall 37.5%) among medicines containing new active ingredients authorized by the European Medicines Agency (EMA). Following, in descending order, are anti-infectives for systemic use, drugs for the gastrointestinal tract and metabolism, and for the nervous system. During 2022, EMA authorized 20 orphan medicinal products containing new active substances, 5 of which are medicinal products for advanced therapies (specifically, gene therapies), and expressed a positive opinion on 91 new indications of 67 already authorized medicinal products. The largest number of new therapeutic indications concerns antineoplastic and immunomodulatory drugs, which with 43 new indications represent 47.3% of the total. 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 hematology-haemostasiology, endocrinology-gynecology-metabolism, neurology and vaccines.

April 04, 2023
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