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EMA recommends approval of abiraterone and thiotepa generics

Generics/News | Posted 02/04/2021 0 Post your comment

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].

EMA recommends approval of adalimumab biosimilar Yuflyma

Generics applications under review by EMA July 2020

Biosimilars approved in Europe

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 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