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

Generics/News | Posted 07/05/2021 post-comment0 Post your comment

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.

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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].

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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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