EMA recommends approval for two new generics Posted 06/12/2019

The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced in November 2019 seven new medicines recommended for approval, including Isturisa (osilodrostat) for the treatment of hormonal disorder Cushing’s syndrome and multiple sclerosis drug Mayzent (siponimod), both of which are produced by Novartis. 

The CHMP also recommended marketing authorization for two generic medicines: clopidogrel/acetylsalicylic acid and deferasirox.

Clopidogrel is an antiplatelet drug used to reduce the risk of heart disease and stroke. When combined with aspirin (acetylsalicylic acid) it can be used to treat myocardial infarction and following surgery to place a stent in a coronary artery. A recent study [1] found that generic clopidogrel is equally effective as the originator drug (marketed as Plavix) in treatment of patients with acute coronary syndrome. The EMA-recommended generic is produced by generics giant Mylan. 

The second recommended generic, deferasirox, is an iron chelator used to reduce levels of excess iron in patients receiving long-term blood transfusions for chronic anemias, such as the genetic disorder β-thalassemia. The generic version has been produced by UK-based drugmaker Accord Healthcare. 

Accord also recently received EMA approval for two generic drugs based on posaconazole, which is an antifungal medicine used to treat a range of fungal infections [2]. The generics are both copies of Noxafil, sold in the European Union since 2005. 

Related articles
Generics applications under review by EMA – July 2019

Platelet reactivity with generic and brand-name clopidogrel

References
1. GaBI Online - Generics and Biosimilars Initiative. Generic clopidogrel non-inferior to Plavix in acute coronary syndrome [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Generics/Research/Generic-clopidogrel-non-inferior-to-Plavix-in-acute-coronary-syndrome
2. GaBI Online - Generics and Biosimilars Initiative. EMA approves two generics for fungal infections [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Dec 6]. Available from: www.gabionline.net/Generics/News/EMA-approves-two-generics-for-fungal-infections

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Source: European Medicines Agency

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