EMA recommends approval of abiraterone and ioflupane (123I) generics

Genéricos/Novedades | Posted 07/05/2021 post-comment

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The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.

Abiraterone KRKA (abiraterone acetate)
The first product is Abiraterone KRKA (abiraterone acetate), for the treatment of adult men with metastatic prostate cancer. This drug treatment is for advanced prostate cancer and is most commonly offered to patients whose cancer has stopped responding to other types of hormone therapy. Abiraterone is a hormone antagonist that inhibits the production of androgens in the testes, adrenal glands and prostatic tumour tissues.

CHMP’s recommendation follows satisfactory studies that have demonstrated the quality of Abiraterone KRKA, and its bioequivalence to the reference originator product, Janssen-Cilag’s Zytiga. Abiraterone KRKA will be licensed for the same indications as Zytiga. It joins another generic of the product, Abiraterone Accord (abiraterone), which received a positive opinion towards the recommendation for approval by EMA in early 2021 [1].

Celsunax (ioflupane (¹²³I)
In addition, Celsunax (ioflupane (¹²³I)) also received CHMP’s recommendation. This product is a radioactive diagnostic tool with an originator product first developed by GE Healthcare [2]. This generic Celsunax is intended for detecting loss of functional dopaminergic neuron terminals in the striatum, this is relevant to the diagnosis of Parkinson’s disease and other related diseases and dementia [3].

Way cleared in US for Suboxone and Zytiga generics

Generics applications under review by EMA July 2020

LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of abiraterone and thiotepa generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Generics/News/EMA-recommends-approval-of-abiraterone-and-thiotepa-generics
2. GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA January 2021 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-January-2021
3. GaBI Online - Generics and Biosimilars Initiative. EMA approves hypertension and Parkinson’s generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Generics/News/EMA-approves-hypertension-and-Parkinson-s-generics

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