Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP

Generics/News | Posted 25/03/2022 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 28 January 2022 that three generic medicines had received a positive opinion from the committee.

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The three generic medicines are: dasatinib Accord (dasatinib) and dasatinib Accord Pharma (dasatinib) for the treatment of leukaemia, and vildagliptin/metformin hydrochloride Accord (vildagliptin/metformin hydrochloride) for the treatment of type 2 diabetes. The dasatinib originator is Sprycel produced by Bristol-Myers Squibb whereas the vildagliptin/metformin hydrochloride originator is made by Novartis and has a variety of brand names including eucreas, icandra and zomarist [1].

The three generic medicines are all produced by India-based generics maker Accord Healthcare (a subsidiary of Intas Pharmaceuticals). Accord’s teriparatide biosimilar Sondelbay, also received a positive opinion from the committee in the announcement [2].

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The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA January 2022 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/generics/general/generics-applications-under-review-by-ema-january-2022
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of teriparatide and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Mar 25]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-teriparatide-and-pegfilgrastim-biosimilars

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