During the CHMP’s meeting of 23−26 April 2019, the committee recommended granting marketing authorizations for two generics: Ambrisentan Mylan (ambrisentan), for the treatment of pulmonary arterial hypertension, and Striascan [ioflupane (123I)], a radiopharmaceutical intended for the diagnosis of Parkinson’s disease and other related diseases and dementia.

Ambrisentan Mylan is a generic version of GlaxoSmithKline’s endothelin receptor antagonist (ERA) Volibris (ambrisentan). Volibris is indicated for the treatment of pulmonary hypertension, which is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart.

Striascan is made by CIS BIO International. It is a generic version of GE Healthcare’s DaTSCAN [ioflupane (123I)], which is a neuro-imaging radiopharmaceutical drug, used by nuclear medicine physicians for the diagnosis of Parkinson's disease and the differential diagnosis of Parkinson's disease over other disorders presenting similar symptoms.

Ambrisentan Mylan has been approved as 5 mg and 10 mg film-coated tablets. Striascan has been approved as a solution for injection (74 MBq/mL). The CHMP states that studies for both generics have demonstrated the satisfactory quality of the two products and their bioequivalence to the relevant reference products.

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Generics applications under review by EMA – January 2019

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