EMA recommends approval of abiraterone and thiotepa generics Posted 02/04/2021

In January and February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) held meetings that led to positive opinions towards the recommendation for approval of two generics, Abiraterone Accord (abiraterone) and Thiotepa Riemser (thiotepa).

Abiraterone Accord is a generic version of Janssen-Cilag’s metastatic prostate cancer drug Zytiga (abiraterone). The newly approved Accord Healthcare S.L.U. product will be available as 250 mg tablet and 500 mg film-coated tablet. Abiraterone is a hormone antagonist that inhibits the production of androgens in the testes, adrenal glands and prostatic tumour tissues.

Thiotepa Riemser is a generic version of Adienne’s chemotherapy drug, Tepadina (thiotepa). The applicant is Riemser Pharma GmbH and the product will now be available as 15 mg and 100 mg powder for concentrate for solution for infusion. Thiotepa is a conditioning chemotherapy treatment to be used before haematopoietic progenitor cell (cells that make blood cells) transplantation. It is indicated for use in combination with other chemotherapy medicinal products.

The early 2021 meetings also led to EMA’s approval of AstraZeneca’s COVID-19 vaccine [1] and four biosimilar versions of bevacizumab [2].

Related articles
Biosimilars applications under review by EMA January 2021

EMA recommends approval of adalimumab biosimilar Yuflyma

Generics applications under review by EMA July 2020

Biosimilars approved in Europe

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approves fourth COVID-19 vaccine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Generics/News/EMA-recommends-approval-of-fourth-COVID-19-vaccine 
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of four bevacizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-four-bevacizumab-biosimilars

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Source: EMA

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