In its ‘2023 Human Medicines Highlights’, the European Medicines Agency (EMA) provided a comprehensive overview of key recommendations for the approval of medicines in various therapeutic areas. Notably, the report highlighted significant advancements in cancer treatment approvals, including cancer biosimilar.
Highlights of EMA approvals in 2023 focus on cancer medicines
Home/Reports
|
Posted 14/05/2024
0
Post your comment
![04 AA010978 04 AA010978](/var/gabi/storage/images/media/images/04-aa010978/25742-1-eng-GB/04-AA010978_large.jpg)
In 2023, the EMA recommended 77 medicines for marketing authorization, including 39 with novel active ingredients previously unapproved in the EU. Some of these medications notably address public health concerns or showcase innovative advancements.
EMA plays a pivotal role in the evaluation and regulation of medicines within the European Union, with the aim to improve patient access to vital treatments while ensuring safety and efficacy standards are met.
Until 2023, EMA has recommended the approval of 93 biosimilars [1], with eight of them recommended in 2023 alone, they are:
1. Cancer
Herwenda (trastuzumab)
2. Haematology/Haemostaseology
Bekemv (eculizumab)
Epysqli (eculizumab)
3. Immunology/ Rheumatology/ Transplantation
Tyenne (tocilizumab)
Uzpruvo (ustekinumab)
4. Neurology
Tyruko (natalizumab)
5. Ophthalmology
Rimmyrah (ranibizumab)
Yesafili (aflibercept)
The latest estimates, released on 1 February 2024 by the World Health Organization’s International Agency for Research on Cancer, predict that there will be over 35 million new cancer cases in 2050, representing a 77% increase from the estimated 20 million cases in 2022 [2].
Among the 2023 EMA marketing authorization, 25 were for cancer treatment. Authorization of new medicines is essential for advancing public health as they offer new opportunities to treat certain diseases. Table 1 presents a selection of cancer medicines recommended for approval in 2023, showcasing significant advancements in their respective therapeutic areas.
Table 1: EMA recommended approval of cancer medicines in 2023 |
Product name | Target/Therapeutic area |
Columvi (glofitamab) and Tepkinly (epcoritamab) | Diffuse large B-cell lymphoma, an aggressive type of non-Hodgkin lymphoma |
Elrexfio (elranatamab) | Adult patients with relapsed or refractory multiple myeloma |
Finlee (dabrafenib) in combination with Spexotras (trametinib) | Paediatric patients aged one year and older with glioma, a type of brain tumour |
Jaypirca (pirtobrutinib) | Relapsed or refractory mantle cell lymphoma which develops when B-cells, a type of white blood cell that makes antibodies, become abnormal |
Krazati (adagrasib) | Adults with advanced non-small cell lung cancer with a G12C mutation in the KRAS gene whose disease has worsened after at least one systemic treatment |
Lytgobi (futibatinib) | Cholangiocarcinoma or bile duct cancer |
Omjjara (momelotinib) | For myelofibrosis, a rare blood cancer that affects the bone marrow |
Pedmarqsi (sodium thiosulfate) | For the prevention of ototoxicity induced by cisplatin chemotherapy in children from one month up to 18 years of age |
Talvey (talquetamab) | Adult patients with relapsed and refractory multiple myeloma, a rare cancer of the bone marrow |
The approval of several cancer treatment medicines in 2023, as outlined in Table 1, marks a significant milestone in the field of oncology and broader public health. These medications, ranging from novel targeted therapies to biosimilars, represent promising advancements in the fight against cancer, addressing diverse forms of the disease such as lymphoma, multiple myeloma, lung cancer, and more.
Related article
ASCO policy statement on biosimilars and interchangeables in oncology updated
LATIN AMERICAN FORUM View the latest headline article: Bio-Thera y SteinCares firman acuerdo para comercializar dos biosimilares en LATAM Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
FORO LATINOAMERICANO Ver el último artículo de cabecera: Bio-Thera y SteinCares firman acuerdo para comercializar dos biosimilares en LATAM !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. |
References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in cancer treatment in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/reports/biosimilars-in-cancer-treatment-in-europe-and-the-us
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.
Policies & Legislation
China’s NMPA expands global ties with Netherlands and Indonesia
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Challenges and solutions in addressing the development void for oncology biosimilars
![150 AA010692 150 AA010692](/var/gabi/storage/images/media/images/150-aa0106922/21852-1-eng-GB/150-AA010692_large.jpg)
Home/Reports Posted 13/08/2024
Role of biologicals and biosimilars in cancer treatment amidst rising cases
![Cancer Cell V13I20 Cancer Cell V13I20](/var/gabi/storage/images/media/images/cancer-cell-v13i20/19527-1-eng-GB/Cancer-Cell-V13I20_large.jpg)
Home/Reports Posted 06/08/2024
FDA plans to standardize biosimilar approvals and boost access in FY 2025
![22 AA010963 22 AA010963](/var/gabi/storage/images/media/images/22-aa010963/36186-1-eng-GB/22-AA010963_large.jpg)
Home/Reports Posted 30/07/2024
The best selling biotechnology drugs of 2008: the next biosimilars targets
![picture09 picture09](/var/gabi/storage/images/media/images/picture09/2207-2-eng-GB/picture09_large.jpg)
Post your comment