During the CHMP’s meeting of 16−19 September 2019, the committee recommended granting marketing authorizations for three generics: Arsenic trioxide Accord (arsenic trioxide), for the treatment of acute promyelocytic leukaemia; Bortezomib Fresenius Kabi (bortezomib), for the treatment of multiple myeloma and mantle cell lymphoma; and Ivozall (clofarabine), for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients.

Arsenic trioxide Accord is a generic version of the originator product Trisenox (arsenic trioxide), which is made by Teva Pharmaceutical Laboratories (Teva), and was approved in Europe in March 2002. Trisenox is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation’ (when there is a swap of genes between two chromosomes). The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). Patients with APL are normally treated with retinoids (substances derived from vitamin A).

Bortezomib Fresenius Kabi is a generic version of Janssen-Cilag’s Velcade (bortezomib), which was approved in Europe in April 2004. Velcade is used to treat multiple myeloma, a blood cancer, in previously untreated adults who cannot have high-dose chemotherapy with a blood stem-cell transplant (in combination with melphalan and prednisone), in previously untreated patients who are going to receive high-dose chemotherapy followed by a blood stem-cell transplant (in combination with dexamethasone, or with dexamethasone plus thalidomide) and in adults whose disease is getting worse after at least one other treatment and who have already had, or cannot undergo, a blood stem-cell transplant (either on its own or in combination with pegylated liposomal doxorubicin or dexamethasone). 

Orphelia Pharma’s Ivozall is a generic version of Genzyme’s Evoltra (clofarabine), which was approved in Europe in May 2006. Evoltra is used to treat children and adults up to 21 years of age who have ALL, which is a cancer of the lymphocytes (a type of white blood cell). It is used when the disease has not responded to or has come back (relapsed) after at least two other treatments, and when no other treatment is expected to work

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Generics applications under review by EMA – July 2019

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